CLINICAL TRIALS PROFILE FOR VYVANSE

505(b)(2) Clinical Trials for VYVANSE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00746733 ↗	Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC	Completed	Shire	Phase 1	2008-09-08	The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.

All Clinical Trials for VYVANSE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00735371 ↗	Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)	Completed	Shire	Phase 3	2008-10-08	The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.
NCT00733356 ↗	The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading	Completed	Shire	Phase 4	2008-07-01	This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
NCT00733356 ↗	The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading	Completed	Kimberley Lakes	Phase 4	2008-07-01	This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
NCT00733356 ↗	The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading	Completed	University of California, Irvine	Phase 4	2008-07-01	This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
NCT00573534 ↗	Pilot Study of Vyvanse™ In ADHD Adolescents at Risk for Substance Abuse	Completed	New York State Psychiatric Institute	Phase 4	2008-03-01	This is an open label pilot study to obtain information on the best way to study young adolescents with Attention Deficit Hyperactivity Disorder (ADHD)who may also be at risk of developing substance abuse, in part because of their ADHD. The plan is to recruit older children/young adolescents (age 11-15) who have ADHD and also have an older sibling with substance abuse. The treatment for ADHD in the 11-15 year old will be Vyvanse, a novel preparation of dextroamphetamine in which the molecule is inactivated and only becomes activated when it is digested. This preparation is felt to be safer from diversion while at the same time providing treatment for the younger siblings in which a bad outcome has already occurred in the family, namely the older sibling's substance abuse. As mentioned, this is an open-label study, a feasibility study to see if we can use this approach to study and treat high risk youth before they develop substance abuse.
NCT00500071 ↗	Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD	Completed	Shire	Phase 4	2007-06-28	Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
NCT00500149 ↗	A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)	Completed	Shire	Phase 3	2007-06-13	The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

Clinical Trial Conditions for VYVANSE

Condition Name

Condition Name for VYVANSE
Intervention	Trials
Attention Deficit Hyperactivity Disorder	15
ADHD	6
Attention-deficit/Hyperactivity Disorder	5
Attention Deficit Hyperactivity Disorder (ADHD)	5

Condition MeSH

Condition MeSH for VYVANSE
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	38
Hyperkinesis	25
Disease	21
Depressive Disorder	8

Clinical Trial Locations for VYVANSE

Trials by Country

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−

Trials by Country for VYVANSE
Location	Trials
United States	368
Canada	21
Spain	7
Germany	7
United Kingdom	5

Trials by US State

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−

Trials by US State for VYVANSE
Location	Trials
New York	21
Pennsylvania	18
California	18
North Carolina	16
Florida	16

Clinical Trial Progress for VYVANSE

Clinical Trial Phase

Clinical Trial Phase for VYVANSE
Clinical Trial Phase	Trials
Phase 4	30
Phase 3	9
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for VYVANSE
Clinical Trial Phase	Trials
Completed	44
Terminated	8
Unknown status	5

Clinical Trial Sponsors for VYVANSE

Sponsor Name

Sponsor Name for VYVANSE
Sponsor	Trials
Shire	42
University of Pennsylvania	5
Massachusetts General Hospital	4

Sponsor Type

Sponsor Type for VYVANSE
Sponsor	Trials
Other	61
Industry	43
NIH	3

Vyvanse: Clinical Trials, Market Analysis, and Projections

Introduction to Vyvanse

Vyvanse, also known as lisdexamfetamine dimesylate, is a central nervous system (CNS) stimulant used primarily for the treatment of attention-deficit/hyperactivity disorder (ADHD) and moderate-to-severe binge-eating disorder (BED) in adults. Developed by Shire and now part of Takeda's portfolio, Vyvanse has been a significant player in the pharmaceutical market since its FDA approval in 2007 for ADHD and in 2015 for BED[4].

Clinical Trials Overview

ADHD Trials

Clinical trials for Vyvanse in ADHD have been extensive. One notable study is the Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study, which aimed to evaluate the long-term safety of Vyvanse in adolescents aged 13-17. This study, conducted from November 2008 to April 2010, enrolled 269 participants and tested daily morning doses of 30, 50, and 70 mg/day[1].

BED Trials

For BED, the FDA's approval of Vyvanse was based on several clinical studies. These include an 11-week, phase II trial (Study 10) and two 12-week, randomized, double-blind, multi-center, placebo-controlled, dose-optimization studies (Studies 11 and 12). These studies demonstrated the efficacy of Vyvanse in reducing binge-eating episodes, with the 50mg and 70mg doses showing superiority over placebo[4].

Long-Term Efficacy

A longer-term study (Study 13) with a randomized withdrawal design up to 26 weeks further supported the maintenance efficacy of Vyvanse over placebo. This study showed that patients who continued with Vyvanse had a lower relapse rate compared to those on placebo[4].

Common Adverse Events

Clinical trials have identified several common adverse events associated with Vyvanse, including dry mouth, reduced appetite, increased heart rate, insomnia, constipation, anxiety, and a jittery feeling[4].

Market Analysis

Current Market Position

As of 2022, Vyvanse held the largest market share among branded ADHD products, generating approximately $2.5 billion in sales across the US, Japan, Germany, and other countries[3].

Impact of Patent Expiry

The US patent for Vyvanse expired in August 2023, leading to the approval of multiple generic versions by the FDA. However, the uptake of these generics has been slower than expected due to manufacturing delays and shortages of active pharmaceutical ingredients (APIs). This has resulted in a milder-than-anticipated market-share erosion for the branded product[2][3].

Sales Performance

Despite the loss of exclusivity, Vyvanse sales fell 12.1% to 312.9 billion yen ($2.14 billion) during the first nine months of Takeda's 2023 fiscal year. This decline was anticipated, but the market-share erosion was slightly milder due to constraints on generic supplies[2].

Market Projections

Sales Erosion

GlobalData predicts that the API shortages affecting generic Vyvanse will be resolved by 2027, leading to a return to normal generic uptake levels. This will result in significant sales erosion for the branded product, further impacting Takeda's revenue. The ADHD market, including Vyvanse, is forecasted to decline by $1 billion between 2022 and 2032 due to increased competition from generics[3].

Takeda's Strategic Response

To counter the loss of exclusivity and subsequent sales decline, Takeda is focusing on its newer products and pipeline developments. The company aims to return to sales, profit, and margin growth in the near term (fiscal years 2024-2025) and plans to expand the reach of its new medicines in the medium term. Key products include Entyvio for inflammatory bowel disease (IBD) and the dengue fever vaccine Qdenga[2].

Enterprise-Wide Efficiency Program

Takeda is also implementing an enterprise-wide efficiency program starting in fiscal year 2024, aimed at improving operational efficiency at a projected cost of nearly $900 million. This program is part of Takeda's broader strategy to navigate the challenges posed by generic competition[3].

Production Adjustments

In response to the ongoing stimulant shortage, the DEA has approved a 24% production increase for Vyvanse and its generic equivalents. This increase will help address both domestic and foreign demand, ensuring an adequate and uninterrupted supply of the medication[5].

"These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally," the DEA said in a letter on September 5[5].

Key Takeaways

• Clinical Trials: Vyvanse has undergone extensive clinical trials for both ADHD and BED, demonstrating its efficacy and safety.
• Market Position: Despite losing exclusivity, Vyvanse remains a significant player in the ADHD market, though facing increased generic competition.
• Sales Projections: The market is expected to decline due to generic competition, but Takeda is diversifying its portfolio to mitigate this impact.
• Production Adjustments: The DEA has approved increased production to address supply shortages.
• Strategic Response: Takeda is focusing on new products and operational efficiency to return to growth.

FAQs

What is Vyvanse used for?

Vyvanse is used for the treatment of attention-deficit/hyperactivity disorder (ADHD) and moderate-to-severe binge-eating disorder (BED) in adults.

When did Vyvanse lose its patent exclusivity?

Vyvanse lost its US patent exclusivity in August 2023.

How has the loss of exclusivity affected Vyvanse sales?

The loss of exclusivity led to a 12.1% decline in Vyvanse sales during the first nine months of Takeda's 2023 fiscal year, though the market-share erosion was milder than anticipated due to generic supply constraints.

What is Takeda's response to the loss of exclusivity?

Takeda is focusing on its newer products, pipeline developments, and an enterprise-wide efficiency program to return to sales, profit, and margin growth.

Why has the uptake of generic Vyvanse been slower than expected?

The uptake of generic Vyvanse has been slower due to manufacturing delays and shortages of active pharmaceutical ingredients (APIs).

What is the DEA's role in addressing the Vyvanse shortage?

The DEA has approved a 24% production increase for Vyvanse and its generic equivalents to ensure an adequate and uninterrupted supply of the medication.

Sources

1. ClinicalTrials.takeda.com: Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study.
2. Fiercepharma.com: Takeda treads water despite loss of exclusivity on Vyvanse.
3. Drugpatentwatch.com: Pharmaceutical drug prices and trends for VYVANSE.
4. Clinicaltrialsarena.com: Vyvanse® for the Treatment of Binge-Eating Disorder, USA.
5. Additudemag.com: Vyvanse Shortage: ADHD Medication Granted Expanded Production.