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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR OLEPTRO


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All Clinical Trials for Oleptro

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00253890 ↗ Insomnia and Drug Relapse Risk Completed National Institute on Drug Abuse (NIDA) Phase 3 2005-10-01 The purposes of this study are: 1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and 2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.
NCT00253890 ↗ Insomnia and Drug Relapse Risk Completed Butler Hospital Phase 3 2005-10-01 The purposes of this study are: 1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and 2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.
NCT00775203 ↗ A Randomized, Double-blind, Two-arm Study Comparing the Efficacy and Safety of Trazodone Contramid® OAD and Placebo in the Treatment of Unipolar Major Depressive Disorder. Completed Labopharm Inc. Phase 3 2007-06-01 The purpose of this study was to demonstrate efficacy, safety and clinical benefit of Trazodone Contramid® OAD (Once A Day) in the treatment of Unipolar Major Depressive Disorder (MDD).
NCT00839072 ↗ Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers Completed Algorithme Pharma Inc Phase 1 2009-02-01 The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations
NCT00839072 ↗ Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers Completed Labopharm Inc. Phase 1 2009-02-01 The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Oleptro

Condition Name

Condition Name for Oleptro
Intervention Trials
Healthy 3
Insomnia 1
Major Depressive Disorder 1
Mental Health Disorder 1
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Condition MeSH

Condition MeSH for Oleptro
Intervention Trials
Disease 2
Sleep Apnea Syndromes 1
Depression 1
Substance-Related Disorders 1
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Clinical Trial Locations for Oleptro

Trials by Country

Trials by Country for Oleptro
Location Trials
United States 19
Canada 5
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Trials by US State

Trials by US State for Oleptro
Location Trials
Ohio 2
Kansas 1
Indiana 1
Illinois 1
Georgia 1
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Clinical Trial Progress for Oleptro

Clinical Trial Phase

Clinical Trial Phase for Oleptro
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for Oleptro
Clinical Trial Phase Trials
Completed 6
Suspended 1
Terminated 1
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Clinical Trial Sponsors for Oleptro

Sponsor Name

Sponsor Name for Oleptro
Sponsor Trials
Labopharm Inc. 5
National Institute on Drug Abuse (NIDA) 1
Butler Hospital 1
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Sponsor Type

Sponsor Type for Oleptro
Sponsor Trials
Industry 6
U.S. Fed 2
NIH 1
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Clinical Trials, Market Analysis, and Projections for Oleptro (Trazodone Hydrochloride Extended-Release)

Introduction

Oleptro, the extended-release formulation of trazodone hydrochloride, was approved by the U.S. FDA in February 2010 for the treatment of major depressive disorder (MDD) in adults. Here, we delve into the clinical trials that led to its approval, the current market analysis, and future projections.

Clinical Trials Overview

Efficacy and Safety

The efficacy of Oleptro was demonstrated in an eight-week randomized, double-blind, two-arm, multi-center study involving patients with unipolar major depressive disorder. The primary efficacy endpoint was the change in the Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to the end of the study. The results showed a statistically significant improvement in the HAMD-17 score for the Oleptro group compared to the placebo group (p value of 0.012)[2][4].

Adverse Reactions

The clinical trials highlighted several common adverse reactions associated with Oleptro, including somnolence, headache, dizziness, sedation, dry mouth, nausea, fatigue, diarrhea, constipation, back pain, and blurred vision. These adverse events were generally mild to moderate in intensity and transient in nature. The median duration for some of these events was relatively short, such as 9 days for somnolence and 4 days for dizziness[1][2].

Discontinuation Rates

The overall discontinuation rate in the study was 25%, with 21% in the placebo group and 30% in the Oleptro group. Adverse reactions leading to discontinuation included dizziness, sedation, somnolence, and others[2].

Mechanism of Action and Pharmacokinetics

Mechanism of Action

Oleptro is believed to exert its antidepressant effects by selectively inhibiting the neuronal reuptake of serotonin and antagonizing the 5-HT 2A/2C serotonin receptors, although the exact mechanism is not fully understood[4].

Pharmacokinetics

Oleptro is well absorbed after oral administration and is primarily metabolized in the liver by cytochrome P450 3A4. It is highly protein-bound (85%-95%) and predominantly excreted in the kidneys. The mean terminal half-life after a 300-mg single dose is approximately 10 hours[4].

Market Analysis

Market Size and Growth

The U.S. antidepressant market, into which Oleptro was launched, is valued at over $11 billion. The approval of Oleptro provided physicians with another therapeutic alternative for treating MDD, a condition affecting more than 14 million adults in the U.S.[2].

Competitive Landscape

The market for antidepressants is highly competitive, with several key players. Oleptro's unique extended-release formulation, utilizing Labopharm's CONTRAMID technology, differentiates it from other trazodone formulations. However, the generic market for trazodone hydrochloride is also competitive, with multiple generic versions available[5].

Commercialization Strategy

Labopharm explored various commercialization strategies for Oleptro, including out-licensing to a distribution partner and full co-promotion arrangements. The company conducted market research, developed a positioning and marketing campaign, and finalized product manufacturing and packaging arrangements to maximize the product's value in the market[2].

Projections and Future Outlook

Market Growth

The global clinical trials market, which includes trials for antidepressants like Oleptro, is projected to grow at a CAGR of 6.49% from 2024 to 2030. This growth is driven by increasing investment in R&D, the rising prevalence of chronic diseases, and the globalization of clinical trials[3].

Phase III and Beyond

Oleptro's approval was based on Phase III clinical trials, which are the most critical and expensive phase of clinical development. The success of Oleptro in these trials sets a strong foundation for its continued presence in the market. Labopharm is also required to conduct post-approval studies, including a pediatric study and a long-term maintenance study, which will further validate the drug's efficacy and safety profile[2].

Regulatory and Safety Considerations

Oleptro's safety profile, including potential QT prolongation and orthostatic hypotension, necessitates careful monitoring. The FDA has mandated additional studies to address these concerns, ensuring ongoing safety and efficacy evaluations[1][2].

Key Takeaways

  • Clinical Efficacy: Oleptro demonstrated significant efficacy in treating MDD in clinical trials, with a statistically significant improvement in HAMD-17 scores.
  • Safety Profile: Common adverse reactions include somnolence, headache, and dizziness, with most events being mild to moderate and transient.
  • Market Position: Oleptro competes in a highly competitive antidepressant market but offers a unique extended-release formulation.
  • Future Outlook: The drug is expected to benefit from the growing clinical trials market and increasing investment in R&D.

FAQs

What is Oleptro used for?

Oleptro is used for the treatment of major depressive disorder (MDD) in adults.

What is the mechanism of action of Oleptro?

Oleptro is believed to exert its effects by selectively inhibiting the neuronal reuptake of serotonin and antagonizing the 5-HT 2A/2C serotonin receptors.

What are the common adverse reactions associated with Oleptro?

Common adverse reactions include somnolence, headache, dizziness, sedation, dry mouth, nausea, fatigue, diarrhea, constipation, back pain, and blurred vision.

How is Oleptro administered?

Oleptro is administered orally once daily, with initial doses starting at 150 mg and potentially increasing to a maximum of 375 mg per day.

What is the significance of the CONTRAMID technology in Oleptro?

The CONTRAMID technology used in Oleptro controls the release of the active substance, allowing for a once-daily dosing regimen and potentially improving patient compliance.

Sources

  1. Trazodone Hydrochloride Extended-Release Caplets 150 and 300 mg - PDF.hres.ca
  2. U.S. FDA Approves Labopharm's Antidepressant Trazodone - Biospace
  3. Global Clinical Trials Market Size, Share And Growth Report, 2030 - Grand View Research
  4. Labopharm Inc's Oleptro - Pharmacy Times
  5. Trazodone hydrochloride - Generic Drug Details - Drug Patent Watch

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