Stimulant Abuse Deterrents and Treatments - 2018

Stimulant Abuse Deterrents and Treatments: An Assessment of
the Technological, Competitive and R&D Landscape – 2018
EXECUTIVE SUMMARY
Stimulant Abuse Deterrents and
Treatments: An Assessment of the
Technological, Competitive and R&D
Landscape - 2018
 Epidemiology
 Epidemiology Forecast
 Proposed Treatments
 Formulation Strategies
 Abuse Deterrence
Technologies
 Pipeline Analysis
 Clinical Trial Analysis
 Product Approval Timeline
 Deals, Collaborations
 RoA based Analysis New Report:
 MoA based Analysis
June 2018
 Geography based Analysis
 HSD based Analysis
 Product Profiles &
Milestones
 Inactive Projects
 Emerging Companies with
Profiles and Product
Milestones
GervanoRA Data Services LLP

S-2 Block, Goa IT Innovation Center,
Goa Chamber of Commerce and Industry
Bldg. South Goa, Goa, INDIA
403722. Copyright © 2018 by GervanoRA Data Services
ramu.jadhav@gervanora.com (INDIA) sujan.muddasani@gervanora.com (US)
Stimulant Abuse Deterrents and Treatments: An Assessment of the Technological, Competitive and R&D Landscape - 2018
info.uk@gervanora.com (UK) vg.nagapuri@gervanora.com (NEW ZEALAND)

EXECUTIVE SUMMARY
Stimulants are a class of Fi g ur e : Addi ct ed P op ul a ti o n Epi d emi ol og y (20 16), F or e cas t (201 7 -20 25)
drugs that “stimulate”

the brain and the central
nervous system (CNS) to
create alertness and
energy. A stimulant
creates a cycle of feelings
and behavior in the users.
When a person is high on
any stimulant substance,
he starts to feel
energized, happy and
S o ur c e:G er vano RA
very active, but, once the
For analysis, we have segmented the report into Stimulant Drug Abuse
effect of the substance
Deterrents and Cocaine and Methamphetamine Drug Abuse Deterrents.
fades the person starts to
Further, these segments are classified based on geography, drug class,
feel depressed, saddened,
nervous, etc. route of administration, mechanism of action, highest stage of
development and developers (Companies, Universities and Institutes).
EPIDEMIOLOGY HIGHLIGHTS
Illicit Drug Users XX Million
2017
Epidemiology (US) Stimulant Misusers XX Million
Cocaine Misusers XX Million
Methamphetamine Misusers XX Million
Copyright © 2018 by GervanoRA Data Services
EXECUTIVE SUMMARY
Key Pipeline Events

Inflection points are the major events which have a significant
Our analysis on the Stimulant Drug
impact on the overall stimulant addiction market. It includes Abuse deterrent and cocaine-
both historical and upcoming major events that will shape the methamphetamine drug abuse
deterrent pipeline, estimates that
growth of the market. We have considered all new products
one molecule will get approval in
approvals as key pipeline events. All pipeline events have been the second half of 2018. We expect
visualized here in the figure. around 35 molecules will be
approved by the US FDA and EMA
Fi g ur e : K e y Pi pel i ne E ve n ts , 2018 -203 4 within the time span from 2021-
2024
The estimations are based on the

clinical stages and the regulatory
pathways. We have calculated
approval timeline for US Regulatory
and International Approval.
Stimulant Addiction Global Scenarios

 According to data collected from the Canadian Tobacco, Alcohol and Drugs Survey
(CTADS), X.X% of Canadians aged 15 and older reported using cocaine during the past
year in 2015.
 According to European Monitoring Centre for Drugs and Drug Addiction (2016) an
estimated XX million young adults (15–34) used methamphetamine during the last year,
with the most recent national prevalence estimates ranging from 0.1 % to 2.9 %.
EXECUTIVE SUMMARY
Stimulant Addiction Epidemiology

We have built a methodology for forecasting epidemiology by conducting a meticulous study of
the previous affected population in the last decade to understand the epidemiology pattern and
factors associated with it. As part of this study, we assessed various population based sites like,
World Health Organization, National Survey on Drug Use
and Health, United Nations Drug Report and various other
sources for ease of understanding the population trend.
 As per GervanoRA analysis, the
illicit drug user population will Fi g ur e : Addi ct ed P op ul a ti o n Epi d emi ol og y , 201 0 -20 16
increase at a CAGR of XX% from

28.6 million in 2016 to
approximately XX million in 2025.
 We expect that the stimulant
misusers population will grow
from 1.7 million in 2016 to XX
million in 2025 at a growth rate of
XX%.
 GervanoRA expects that the
cocaine use trend will see a linear
growth in population with a
growth rate of XX%.
 As per GervanoRA analysis, the
methamphetamine user Source:GervanoRA
population will increase at a CAGR

of XX% from 0.67 million in 2016
to approximately XX million in
2025.
EXECUTIVE SUMMARY
Pharmacological Proposed Treatments
There are no approved medications

Figure: Pharmacological Treatment Options for Stimulant Addiction
for treatment of stimulant addiction,
especially cocaine and
Agonist
methamphetamine dependence Replacemen
t Therapy
As with most types of addiction, the
first phase of treatment is treatment Dopamine
Opioid
Antagonists
Modulating
detoxification. Moreover, the two Agents
main categories of drug addiction are Pharmacologi
behavioral treatments and cal Treatment
medications. Counseling can be for Stimulant
Serotonin- Addiction
provided at the individual or group and
GABA-
level. Individual counseling usually Noradrenali
Modulatin
ne-
g Agents
focuses on reducing or stopping Modulating
Agents
stimulant use, skill building, Glutamate
-
adherence to a recovery plan, and Modulatin
social, family, and professional and g Agents
educational outcomes.
Source:GervanoRA
Abuse Deterrent Deals Overview

Fi g ur e : D e al M aki ng O v er vi e w , Abu se
D et er r e n t De al s
Around XX deals occurred from the

year 2000 till date involving CNS
stimulants and opioids. These
include acquisition, collaboration
agreements, licensing agreements,
acquisitions and commercialization
agreements.
Source:GervanoRA
EXECUTIVE SUMMARY
Stimulant Abuse Deterrent Formulation Strategies

To reduce or eliminate the Figure: Stimulant Abuse Deterrent Formulation Strategies
potential for the abuse and
misuse of psychoactive or
stimulant pharmaceuticals,
four general formulation
strategies are currently
employed.
An analysis of clinical
development pipeline is
carried out based on
formulation strategies
implemented in the
development of pipeline
molecules in the below table.
Source:GervanoRA
Source:GervanoRA
Stage of Development wise Pipeline Molecules V/s Formulation Strategies

Phase 1 Phase 2 Phase 3 Preclinical Pre-Registered Total
/R&D
Type 1 0 0 0 XX 0 XX
Type 2 0 0 0 XX 0 XX
Type 3 XX XX XX XX XX XX
Type 0 0 0 0 0 0
4(All)
Type 4.1 0 0 0 0 0 0
Type 4.2 0 0 0 0 0 0
Type 4.3 0 0 0 0 0 0
Type 4.4 0 0 0 0 0 0
Totals XX XX XX XX XX 16
Source:GervanoRA
EXECUTIVE SUMMARY
Stimulant Abuse Deterrent Formulation Technologies

To combat the misuse LIQUID-FILLED HARD-CAPSULE TECHNOLOGY (Capsugel)
and abuse, the
development of abuse Description Liquid-filled hard capsule (LFHC) technology provides
deterrent formulation an advanced dosage form – offered in both gelatin and
technologies including HPMC (hypromellose) for liquid, semi-solid, paste and
the reformulation of multiparticulate applications.
Liquid-filled hard capsules address a broad array of
existing products using
formulation challenges, often incorporating a variety
the technology is
of biopharmaceutically-approved lipid and non-lipid
becoming a priority for excipients. Formulation flexibility is a hallmark of
drug manufactures. liquid-filled hard capsule formulation and
manufacturing technology.
We have all the
Applications  Bioavailability
technologies with abuse
 Dose Uniformity
deterrence properties.  High Potency
 API Stability
 Clinical Development Tool
Stimulant Abuse Global Trends and Regulatory Developments

Figure: Comparison between female and male users attributable to drug use disorders, 2005 and 2015
Collated with drug

use among male,
overall drug use
remains quite low in
XX% females. Globally,
XX%
male users tend to
use cocaine and
methamphetamine
three folds than
female users.
Source: GervanoRA
EXECUTIVE SUMMARY
Pipeline Analysis of Cocaine and Methamphetamine Drug Abuse

Deterrent
Pipeline Analysis by Stages of Development Pipeline Analysis by Route of Administration

As per GervanoRA analysis, there are XX
Pharmaceutical companies are developing various molecules in the pipeline that can be orally
drug molecules for the treatment of cocaine and administered. Apart from oral administration,
methamphetamine abuse in different stages of there are XX molecules which can be
development- Phase II, Phase I, Preclinical and intravenously administered and XX molecules
Early R&D. There are no molecules in the Pre-
each that are administered via intramuscular
Registration and Phase III stage of development
for cocaine and methamphetamine abuse. route and multiple routes of administration
There are XX company molecules in the drug respectively.
pipeline, among which, XX molecules are in Phase Figure: Pipeline Analysis by Route of Administration
II, drug
XX molecules in Phase I, XX Preclinical molecules
development.
and XX molecules in the Early R&D Phase of
development.
Pipeline Analysis by Geography
Around XX% of molecules in the pipeline will go for

US regulatory approval and XX% of molecules for
EU approvals.
Pipeline Analysis by Companies, Universities &

Institutes Source: GervanoRA
Currently we have around 18 companies that are

working for pharmacological treatment option for
cocaine and methamphetamine abuse.
For the pharmaceutical companies partnerships

with Universities and Institutes are about gaining
access of a molecule and academic investigators
that can help establish their product portfolio.
EXECUTIVE SUMMARY
Pipeline Analysis of Stimulant Drug Abuse Deterrent

Figure: Pipeline Analysis by Route of Administration
Pipeline Analysis by Stages of
Development
As per GervanoRA analysis, there are 16
company molecules in the pipeline, out of
which, XX molecules are in the Pre-Registration
phase, XX molecules in the Phase III, XX
molecules in Phase II, XX molecules in Phase I,
XX Preclinical molecules and XX molecules in
the Early R&D Phase of drug development.
Pipeline Analysis by Geography
Source: GervanoRA
Around XX% of molecules in the pipeline will Source: GervanoRA
go for US regulatory approval and XX% of Figure: Pipeline Analysis by Geography

molecules for Ex US approvals.
Pipeline Analysis by Drug Class and
Mechanism of Action
GervanoRA has provided a comprehensive

analysis based on the molecules drug class and
mechanism of action. Major drug classes of
Stimulant Drug Abuse Deterrent pipeline drugs
are phenethylamine and piperidine class,
sympathomimetics and Dopamine uptake
Source: GervanoRA
inhibitors.
Pipeline Analysis by Companies, Universities &

XX molecules belong to phenethylamine and
Institutes
piperidine class, XX molecules belongs to Currently we have around 13 companies that are
sympathomimetics and XX molecules belongs working for pharmacological treatment option for
to Dopamine uptake inhibitors. stimulant drug abuse deterrence.
EXECUTIVE SUMMARY
Estimated Drug Approval Timeline

As per GervanoRA Pipeline Analysis, we expect XX We have analyzed the Stimulant
molecules will get regulatory approvals in 2018, XX Abuse Deterrent and Cocaine-
molecules in 2020, XX molecules in 2023, XX molecules Methamphetamine drug abuse
in 2024 and so on till 2034. deterrent pipeline providing the
scenarios for regulatory
Figure: Stimulant Drug Abuse Deterrent Launch Analytics, US and EX
US Approval approvals in the US and
International (ex US). The
Company Molecule HSD Estimated International approval timeline is
Approval
Ironshore HLD200 XX XX
based on the time taken for the
Pharmaceuticals & EU approval process.
Development, Inc.
XX KP415 XX 2022 As part of this study, we assessed
Shire SHP 489 XX XX the average time to be taken for
Altus Formulation XX Phase I XX each stage of drug development.
Source: GervanoRA For our estimation, we have
reviewed the company sourced
Press Releases, Investor
Figure: Cocaine and Methamphetamine Drug Abuse Deterrent Launch
Analytics, US and EX US Approval
Presentations, Annual and
Quarterly Updates, SEC Filings,
Company Molecule HSD Estimated etc.
Approval
Saniona NS2359 XX XX
XX OMS405 Phase II XX
Embera XX XX 2025
NeuroTherapeutics
Medicinova MN-166 XX XX
(ibudilast)
Source: GervanoRA
EXECUTIVE SUMMARY
Clinical Trial Summary
The clinical trials summary gives an insight to ongoing trials, recently completed trials and
planned trials. Some key results of the trials have also been provided in this segment. We have
analyzed the cocaine and methamphetamine drug abuse deterrent pipeline and stimulant drug
abuse deterrent pipeline separately for better insights.
Ongoing Clinical Trials Summary

Pipeline Analysis by Clinical Trial Results
For cocaine and methamphetamine drug For cocaine and methamphetamine drug
abuse, we have considered the phase II abuse, According to GervanoRA’s analysis,
pipeline molecules’ clinical trials to discuss three molecules are undergoing trials- One
their results in this section. The Phase II results in Phase I and two in Phase II. We have
are being provided for the molecules- MN-166 excluded non-industry sponsored and
(ibudilast) of MediciNova, OMS405 of Omeros observational only trials from our analysis.
Corporation, CERC-501 of Cerecor Inc and
Janssen Pharmaceuticals, and, Planned Clinical Trials Summary
SYN117(Nepicastat) of Biotie Therapies. GervanoRA has analysed two molecules will
For stimulant drug abuse deterrent, we have progress towards their clinical study (Phase
provided the key results for the Phase III I) in the coming year and only one molecule
completed trials by giving an overall idea about is currently being planned to initiate with its
the trial design ad its top-line results. Phase II studies for Cocaine and
Methamphetamine drug abuse deterrent.
Ongoing Phase II Clinical Trials

NCT Number Indication Drug Sponsor No. of Start End Date
patients Date
XX Methamphetamine XX XX 126 May November
addiction 2018 2019
XX Cocaine Dependence XX XX 80 May July 2018
2016
Source: GervanoRA
EXECUTIVE SUMMARY
Recently Completed Clinical Trials Withdrawn and Discontinued Projects
For recently completed clinical trials, we Indivior terminated the development of its
have considered the Phase I clinical trials cocaine addiction treatment drug RBP-8000
completed in 2015 and 2017 for cocaine and (Cocaine Esterase for Cocaine Intoxication)
methamphetamine drug abuse deterrent. in 2017 due to clinical complexity on this
relatively small commercial opportunity.
For stimulant drug abuse deterrent, we have
considered 2 trials that have been
completed in April 2017 and one in March
2018 by the companies XX and XX,
respectively.
Current and Future Competitive Landscape

Many clinical stage companies are entering into development of therapeutics which has the
potential to address the unmet needs. Around XX emerging companies are working on developing
medicines with stimulant abuse deterrent properties, and, around XX emerging companies are
focused on the development of therapies for cocaine and methamphetamine addiction disorders.
There are total of XX molecules in the pipeline that are being developed by universities and
institutes for Stimulant drug abuse deterrent and cocaine and methamphetamine drug abuse
deterrent.
EXECUTIVE SUMMARY
Emerging Company Profiles with Drug Descriptions and Milestones

 Cocaine and Methamphetamine Drug Abuse Deterrent Emerging
Companies
Praxis Biosresearch is a privately-held biopharmaceutical company focused on the

discovery and development of novel prodrug stimulants for treatment of a range of
chronic neuropsychiatric and neurodegenerative disorders. The company has a talented
and proven collection of experts in prodrug design, neuroscience, chemistry,
pharmacology and drug development. Sandeep Patil is the Co-Founder and CEO of the
company.
The company’s lead candidate is PRX-P4-003 being investigated for binge eating disorder
and apathy in Alzheimer’s disease.
PRX-P4-003
Highest Stage of Development It is in Early R&D stage for the treatment of cocaine addiction
Drug Molecule Description PRX-P4-003 is an orally and intravenously administered novel,
abuse-deterrent prodrug stimulant intended for the treatment of
cocaine addiction. It is abuse-deterrent dopamine norepinephrine
reuptake inhibitor incorporating an active isomer of
fencamfamine.
 Stimulant Drug Abuse Deterrent Emerging Companies
Cingulate therapeutics is a privately held, clinical stage biopharmaceutical company focused on

the development of innovative new products for the treatment of Attention Deficit/Hyperactivity
Disorder (ADHD). The company has offices in Kansas City, KS and Morristown, NJ and is a
member of BioKansas and BioNJ. Shane J. Schaffer serves as the CEO and Raul R. Silva serves as
the Chief Scientific Officer of the company.
It is currently developing two proprietary, first-line medications, CTx-1301 (dexmethylphenidate)

and CTx-1302 (dextroamphetamine), via the accelerated 505 (b) (2) regulatory pathway for the
EXECUTIVE SUMMARY
treatment of ADHD patients. It intends to seek additional regulatory approvals where the ADHD
market is also substantial, growing and faces the same unmet medical needs.
The company is open for any partnerships related to future products and in-licensing
opportunities for central nervous systems and other neurobiological disorders as well as new
indications for current assets.Bio-images Drug Delivery Ltd (BDD), Camargo Pharmaceutical
Services, Lowenstein Sandler, ProPharma Group, Inc., Tiberend Strategic Advisors, Inc. and Mintz
Levin, a boston institute are its Key partners.
CTx-1302
Highest Stage of Development It is in Preclinical stage for the treatment of ADHD
Drug Molecule Description CTx-1302 is an oral CNS stimulant utilizing breakthrough multi-
core formulation of dextroamphetamine.
Future Molecule Milestone  Cingulate Therapeutics will submit an IND with the US
FDA by the close of 2018.
 Cingulate Therapeutics plans to initiate Phase I/II studies
for CTx-1302 in early 2019.
Stimulant Abuse Deterrents and Treatments: An Assessment of the
Technological, Competitive and R&D Landscape – 2018
EXECUTIVE SUMMARY
TABLE OF CONTENTS
LIST OF TABLES
LIST OF FIGURES
1. INTRODUCTION
1.1. REPORT DESCRIPTION
1.2. METHODOLOGY
1.3. UPCOMING AND OTHER AVAILABLE PIPELINE ANALYSIS REPORTS
1.4. ABOUT US: GERVANORA DATA SERVICES
2. EXECUTIVE SUMMARY
2.1. REPORTS MAJOR FINDINGS
2.2. KEY PIPELINE EVENTS 2018 TO 2034
3. STIMULANT ADDICTION (COCAINE & METHAMPHETAMINE) MARKET OVERVIEW
3.1. STIMULANT ADDICTION OVERVIEW
3.2. STIMULANT ADDICTION GLOBAL SCENARIOS
3.3. STIMULANT ADDICTION EPIDEMIOLOGY
3.4. EPIDEMIOLOGY FORECAST
3.4.1. FORECAST METHODOLOGY AND ASSUMPTION
3.4.2. PROBABILISTIC EPIDEMIOLOGY FORECAST
3.5. STIMULANT ADDICTION PROPOSED TREATMENTS
4. STIMULANT ABUSE OVERVIEW
4.1. STIMULANT ABUSE AND DETERRENCE
4.2. FACTORS AFFECTING ON STIMULANT ABUSE
4.3. EFFECTS AND SYMPTOMS OF STIMULANT ABUSE
4.4. CURRENT TREATMENTS OF STIMULANT ABUSE
4.5. STIMULANT ABUSE – IMPACT ON HEALTH, SOCIAL AND ECONOMY
EXECUTIVE SUMMARY
5. ABUSE DETERRENT DEALS OVERVIEW

5.1. DEALS (MERGERS/ ACQUISITIONS / COLLABORATIONS)
5.1.1. COLLABORATION AGREEMENTS
5.1.2. LICENSING AGREEMENTS
5.1.3. TERMINATION AGREEMENTS AND SETTLEMENTS
5.1.4. FUNDING & CONTRACTS
5.1.5. PARTNERSHIPS
5.1.6. ACQUISITIONS
6. STIMULANT ABUSE DETERRENTS-RECENT DEVELOPMENTS AND TECHNOLOGIES
6.1. STIMULANT ABUSE DETERRENT FORMULATION STRATEGIES
6.2. STIMULANT ABUSE DETERRENT FORMULATION TECHNOLOGIES
6.3. INTERNATIONAL GUIDELINES FOR ABUSABLE SUBSTANCES
6.4. UNMET MEDICAL NEEDS AND GAPS IN THE TREATMENT OF STIMULANT ABUSE
6.5. STIMULANT ABUSE GLOBAL TRENDS AND REGULATORY DEVELOPMENTS
6.6. LIMITATIONS OF STIMULANT ABUSE DETERRENT FORMULATIONS
7. PIPELINE ANALYSIS OF COCAINE AND METHAMPHETAMINE DRUG ABUSE DETERRENT
7.1. THERAPEUTICS UNDER DEVELOPMENT BY STAGE OF DEVELOPMENT
7.1.1. PHASE II MOLECULES
7.1.2. PHASE I MOLECULES
7.1.3. PRECLINICAL MOLECULES
7.1.4. EARLY R&D MOLECULES
7.1.5. INACTIVE MOLECULES
7.2. PIPELINE ANALYSIS BY GEOGRAPHY
7.3. PIPELINE ANALYSIS BY ROUTE OF ADMINISTRATION
7.4. PIPELINE ANALYSIS BY COMPANIES, UNIVERSITIES & INSTITUTES
8. PIPELINE ANALYSIS OF STIMULANT DRUG ABUSE DETERRENT
EXECUTIVE SUMMARY
8.1. PIPELINE ANALYSIS BY STAGE OF DEVELOPMENT

8.1.1. PRE-REGISTRATION (FILED) MOLECULES
8.1.2. PHASE III MOLECULES
8.1.3. PHASE II MOLECULES
8.1.4. PHASE I MOLECULES
8.1.5. PRECLINICAL MOLECULES
8.1.6. EARLY R&D (DISCOVERY) MOLECULES
8.2. PIPELINE ANALYSIS BY GEOGRAPHY
8.3. PIPELINE ANALYSIS BY ROUTE OF ADMINISTRATION
8.4. PIPELINE ANALYSIS BY DRUG CLASS
8.5. PIPELINE ANALYSIS BY MECHANISM OF ACTION
8.6. PIPELINE ANALYSIS BY COMPANIES, UNIVERSITIES & INSTITUTES
9. ESTIMATED DRUG APPROVAL TIMELINES
9.1. METHODOLOGY
9.2. STIMULANT DRUG ABUSE DETERRENT LAUNCH ANALYTICS
9.2.1. UNITED STATES (FDA) ESTIMATIONS
9.2.2. EX-UNITED STATES (EMA AND INTERNATIONAL) ESTIMATIONS
9.3. COCAINE&METHAMPHETAMINE DRUG ABUSE DETERRENT LAUNCH ANALYTICS
9.3.1. UNITED STATES (FDA) ESTIMATIONS
9.3.2. EX-UNITED STATES (EMA AND INTERNATIONAL) ESTIMATIONS
10. CLINICAL TRIAL SUMMARY
10.1. COCAINE AND METHAMPHETAMINE DRUG ABUSE DETERRENT
10.1.1. PIPELINE ANALYSIS BY CLINICAL TRIAL RESULTS
10.1.2. ONGOING CLINICAL TRIALS SUMMARY
10.1.3. PLANNED CLINICAL TRIAL SUMMARY
10.1.4. RECENTLY COMPLETED CLINICAL TRIALS
EXECUTIVE SUMMARY
10.2. STIMULANT DRUG ABUSE DETERRENT

10.2.1. PIPELINE ANALYSIS BY CLINICAL TRIAL RESULTS
10.2.2. PLANNED CLINICAL TRIAL SUMMARY
10.2.3. RECENTLY COMPLETED TRIALS
10.3. WITHDRAWN AND DISCONTINUED PROJECTS
11. CURRENT AND FUTURE COMPETITIVE LANDSCAPE
11.1. EMERGING COMPANIES
11.2. EMERGING COMPANY PROFILES WITH DRUG DESCRIPTIONS AND MILESTONES
11.2.1. COCAINE AND METHAMPHETAMINE DRUG ABUSE DETERRENT EMERGING
COMPANIES
11.2.2. STIMULANT DRUG ABUSE DETERRENT EMERGING COMPANIES
11.3. UNIVERSITIES AND INSTITUTES
12. ABBREVIATIONS
List of Tables
TABLE 1: METHAMPHETAMINE V/S COCAINE
TABLE 2: ILLICIT DRUG USERS EPIDEMIOLOGY (2016), FORECAST (2017-2025)
TABLE 3: STIMULANT USERS EPIDEMIOLOGY (2016), FORECAST (2017-2025)
TABLE 4: COCAINE USERS EPIDEMIOLOGY (2016), FORECAST (2017-2025)
TABLE 5: METHAMPHETAMINE USERS EPIDEMIOLOGY (2016), FORECAST (2017-2025)
TABLE 6: COLLABORATION AGREEMENTS, 2000-2018
TABLE 7: LICENSING AGREEMENTS, 2013-2018
TABLE 8: TERMINATION AGREEMENTS
TABLE 9: FUNDING AND CONTRACT
TABLE 10: PARTNERSHIP DEALS
TABLE 11: ACQUISITION DEALS
TABLE 12: STAGE OF DEVELOPMENT WISE PIPELINE MOLECULES V/S FORMULATION
STRATEGIES
EXECUTIVE SUMMARY
TABLE 13: MOLECULES BELONGING TO TYPE 3 FORMULATION STRATEGY

TABLE 16: COCAINE AND METHAMPHETAMINE DRUG ABUSE DETERRENT PHASE II PIPELINE
MOLECULES
TABLE 17: COCAINE AND METHAMPHETAMINE DRUG ABUSE DETERRENT PHASE I PIPELINE
MOLECULES
TABLE 18: COCAINE AND METHAMPHETAMINE DRUG ABUSE DETERRENT PRECLINICAL STAGE
PIPELINE MOLECULES
TABLE 19: COCAINE AND METHAMPHETAMINE DRUG ABUSE DETERRENT EARLY R&D PIPELINE
MOLECULES
TABLE 20: COCAINE AND METHAMPHETAMINE DRUG ABUSE DETERRENT INACTIVE PIPELINE
MOLECULES
TABLE 21: COCAINE AND METHAMPHETAMINE DRUG ABUSE DETERRENT PIPELINE ANALYSIS BY
ROUTE OF ADMINISTRATION
TABLE 22: PRE-REGISTRATION (FILED) MOLECULES IN THE STIMULANT DRUG ABUSE PIPELINE
TABLE 23: PHASE III MOLECULES IN THE STIMULANT DRUG ABUSE PIPELINE
TABLE 24: PHASE II MOLECULES IN THE STIMULANT DRUG ABUSE PIPELINE
TABLE 25: PHASE I MOLECULES IN THE STIMULANT DRUG ABUSE PIPELINE
TABLE 26: PRECLINICAL MOLECULES IN THE STIMULANT DRUG ABUSE PIPELINE
TABLE 27: EARLY R&D MOLECULES IN THE STIMULANT DRUG ABUSE PIPELINE
TABLE 28: LIST OF COMPANIES WITH PIPELINE MOLECULES BY STAGE OF DEVELOPMENT
TABLE 29: LIST OF UNIVERSITIES AND INSTITUTES WITH PIPELINE MOLECULES
TABLE 30: STIMULANT DRUG ABUSE DETERRENT LAUNCH ANALYTICS, US APPROVAL
TABLE 31: STIMULANT DRUG ABUSE DETERRENT LAUNCH ANALYTICS, EX US APPROVAL
TABLE 32: COCAINE AND METHAMPHETAMINE DRUG ABUSE DETERRENT LAUNCH ANALYTICS,
US APPROVAL
TABLE 33: COCAINE AND METHAMPHETAMINE DRUG ABUSE DETERRENT LAUNCH ANALYTICS,
EX US APPROVAL
TABLE 34: MN-166 (IBUDILAST) PHASE II CLINICAL TRIAL STUDY DESIGN
TABLE 35: SYN117 (NEPICASTAT) PHASE II CLINICAL TRIAL STUDY DESIGN
TABLE 36: MEASURED VALUE FOR PRIMARY MEASURE- ABSTINENCE
TABLE 37: MEASURED VALUE FOR SECONDARY MEASURE- REDUCTION IN USE
TABLE 38: ONGOING PHASE II CLINICAL TRIALS
TABLE 39: ORADUR-METHYLPHENIDATE ER PHASE III CLINICAL TRIALS STUDY DESIGN
EXECUTIVE SUMMARY
TABLE 40: HLD200 PHASE III CLINICAL TRIALS STUDY DESIGN

TABLE 41: HLD200 SECOND PIVOTAL PHASE III CLINICAL TRIALS STUDY DESIGN
TABLE 42: HLD100 PHASE II TRIAL RESULTS
TABLE 43: RBP-8000 PHASE II CLINICAL TRIALS STUDY DESIGN
TABLE 44: LIST OF UNIVERSITIES AND INSTITUTES
List of Figures
FIGURE 1: KEY PIPELINE EVENTS, COCAINE AND METHAMPHETAMINE DRUG ABUSE
DETERRENT, 2021-2023
FIGURE 2: KEY PIPELINE EVENTS, COCAINE AND METHAMPHETAMINE DRUG ABUSE
DETERRENT, 2024-2028
FIGURE 3: KEY PIPELINE EVENTS, STIMULANT DRUG ABUSE DETERRENT, 2018-2034
FIGURE 4: COCAINE USE TRENDS, US, 2002-2016
FIGURE 5: COCAINE USE TRENDS, CANADA, 2004-2009
FIGURE 6: RELATIVE COMPARISION IN PREVALENCE OF COCAINE AND METHAMPHETAMINE
DRUG USE, 2009-2013
FIGURE 7: COMPARISION OF COCAINE USERS BY AGE GROUP, 2015-2016
FIGURE 8: COMPARISION OF METHAMPHETAMINE USERS BY AGE GROUP, 2015-2016
FIGURE 9: COCAINE USE, 2015-2016
FIGURE 10: ILLICIT DRUG USERS, US, 2010-2016
FIGURE 11: PREVALENCE OF COCAINE USE, AGE GROUP, CANADA, 2008-2015
FIGURE 12: ILLICIT DRUG USERS AGED 12 AND OLDER; FORECAST (2017-2025)
FIGURE 13: STIMULANT USERS AGED 12 AND OLDER; FORECAST (2017-2025)
FIGURE 14: COCAINE USERS AGED 12 AND OLDER; FORECAST (2017-2025)
FIGURE 15: METHAMPHETAMINE USERS AGED 12 AND OLDER; FORECAST (2017-2025)
FIGURE 16: PHARMACOLOGICAL TREATMENT OPTIONS FOR STIMULANT ADDICTION
FIGURE 17: DEAL ACTIVITY, CNS STIMULANTS AND OPIOIDS
FIGURE 18: STRATEGIES FOR STIMULANT ABUSE DETERRENT FORMULATION
FIGURE 19: ANNUAL PREVALENCE AND NUMBER OF ILLICIT DRUG USERS AT THE GLOBAL LEVEL,
2010
FIGURE 20: ILLICIT DRUG USE AT THE GLOBAL LEVEL, 2008
FIGURE 21: COMPARISION BETWEEN FEMALE AND MALE USERS ATTRIBUTABLE TO DRUG USE
DISORDERS, 2005 AND 2015
EXECUTIVE SUMMARY
FIGURE 22: DALY’S COMPARISION BETWEEN FEMALE AND MALE USERS ATTRIBUTABLE TO
DRUG USE DISORDERS, 2005 AND 2015
FIGURE 23: ANNUAL PREVALENCE OF THE USE OF COCAINE AND METHAMPHETAMINE BY
REGION AND GLOBALLY, 2015
FIGURE 24: COCAINE AND METHAMPHETAMINE DRUG ABUSE DETERRENT PIPELINE ANALYSIS
BY ROUTE OF ADMINISTRATION
FIGURE 25: STIMULANT DRUG ABUSE DETERRENT PIPELINE ANALYSIS BY STAGES OF
DEVELOPMENT- COMPANIES
FIGURE 26: STIMULANT DRUG DETERRENT PIPELINE ANALYSIS BY GEOGRAPHY
Abbreviations
SWOT – Strengths Weakness Opportunities Threats
RoA – Route of Administration
MoA– Mechanism of Action
USFDA¬– The United States Food and Drug Administration
EMA– European Medicines Agency
CNS – Central Nervous System
CTADS– Canadian Tobacco, Alcohol and Drugs Survey
CAGR – Compound Annual Growth Rate
GABA– Gamma-Aminobutyric Acid
NA – Noradrenaline
SNRI–Serotonin- and Noradrenaline Reuptake Inhibitor
Meth–Methamphetamine
NIDA–National Institute on Drug Abuse
EXECUTIVE SUMMARY
NIH–National Institute of Health
ER– Extended Release
CDMO–Contract Development and Manufacturing Organization
VNO– Vomeronasal Organ
NDA–New Drug Application
OINV –Opioid-induced nausea and vomiting
OGD– Office of Generic Drugs
PK– Pharmacokinetic
NIPTE – National Institute for Pharmaceutical Technology and Education
DEA – Drug Enforcement Administration
ADF– Abuse Deterrent Formulations
ADHD– Attention-Deficit Hyperactivity Disorder
iADOPT– Abuse Deterrent Overdose Protection Technology
CR/ER –Controlled/Extended release
TIP– Treatment Improvement Protocols
SAMHSA– Substance Abuse and Mental Health Service Administration
CSAT– Center for Substance Abuse Treatment
PPD–Purified Protein Derivative
NACDA– National Advisory Council on Drug Abuse
fMRI –functional Magnetic Resonance Imaging
PET –Positron Emission Tomography
EXECUTIVE SUMMARY
SPECT – Single Photon Emission Computed Tomography
PPRA –Protection of Pupil Rights Amendments
WHO– World Health Organization
ATS –Amphetamine-type Stimulants
DAWN –Drug Abuse Warning Network
DALYs –Disability-Adjusted Life Years
PWID–People Who Inject Drugs
CSA– Studies of Addiction
VMAT2– vesicular monoamine transporter 2
CRADA– Collaborative Research and Development Agreement
DBH –Dopamine Beta-Hydroxylase
FDC –Fixed Dose Combination
PDUFA –Prescription Drug User Fee Act
CEES –Clinical Endpoint Evaluation Study
TEAE –Treatment-Emergent Adverse Event
t.i.d. – Three Times a Day
ONDCP– Office of National Drug Control Policy
CSAP –Center for Substance Abuse Prevention
NCMI –National Methamphetamine and Chemicals Initiative
DFC–Drug-Free Communities
BN– Billion
EXECUTIVE SUMMARY
M–Million
US–United States
EU–Europe

Stimulant Abuse Deterrents and Treatments - 2018

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Stimulant Abuse Deterrents and Treatments: An Assessment of

the Technological, Competitive and R&D Landscape – 2018

GervanoRA Data Services LLP

info.uk@gervanora.com (UK) vg.nagapuri@gervanora.com (NEW ZEALAND)

drugs that “stimulate”

Cocaine Misusers XX Million

Methamphetamine Misusers XX Million

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Key Pipeline Events

The estimations are based on the

Stimulant Addiction Global Scenarios

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Stimulant Addiction Epidemiology

increase at a CAGR of XX% from

population will increase at a CAGR

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Pharmacological Proposed Treatments

There are no approved medications

Abuse Deterrent Deals Overview

Around XX deals occurred from the

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Stimulant Abuse Deterrent Formulation Strategies

Stage of Development wise Pipeline Molecules V/s Formulation Strategies

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Stimulant Abuse Deterrent Formulation Technologies

Stimulant Abuse Global Trends and Regulatory Developments

Collated with drug

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Pipeline Analysis of Cocaine and Methamphetamine Drug Abuse

Pipeline Analysis by Stages of Development Pipeline Analysis by Route of Administration

Pipeline Analysis by Geography

Around XX% of molecules in the pipeline will go for

Pipeline Analysis by Companies, Universities &

Currently we have around 18 companies that are

For the pharmaceutical companies partnerships

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Pipeline Analysis of Stimulant Drug Abuse Deterrent

Around XX% of molecules in the pipeline will Source: GervanoRA

go for US regulatory approval and XX% of Figure: Pipeline Analysis by Geography

GervanoRA has provided a comprehensive

Pipeline Analysis by Companies, Universities &

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Estimated Drug Approval Timeline

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Clinical Trial Summary

Ongoing Clinical Trials Summary

Ongoing Phase II Clinical Trials

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Recently Completed Clinical Trials Withdrawn and Discontinued Projects

Current and Future Competitive Landscape

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Emerging Company Profiles with Drug Descriptions and Milestones

Praxis Biosresearch is a privately-held biopharmaceutical company focused on the

Cingulate therapeutics is a privately held, clinical stage biopharmaceutical company focused on

It is currently developing two proprietary, first-line medications, CTx-1301 (dexmethylphenidate)

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5. ABUSE DETERRENT DEALS OVERVIEW

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8.1. PIPELINE ANALYSIS BY STAGE OF DEVELOPMENT

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10.2. STIMULANT DRUG ABUSE DETERRENT

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TABLE 13: MOLECULES BELONGING TO TYPE 3 FORMULATION STRATEGY

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