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Related Experiment Videos

Selegiline transdermal system Somerset.

Iftekhar Mahmood1

  • 1Division of Clinical Trial Design and Analysis, Center for Biologics Evaluation and Research, Food & Drug Administration, MD 20852, USA. Mahmoodi@CBER.fda.gov

Current Opinion in Investigational Drugs (London, England : 2000)
|September 5, 2002
PubMed
Summary

Somerset is developing a selegiline transdermal system (STS) for depression treatment. The FDA requested more efficacy data for STS approval, impacting its market entry.

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Area of Science:

  • Pharmacology
  • Neurology
  • Drug Development

Background:

  • Selegiline transdermal system (STS) development for depression, Alzheimer's disease (AD), Parkinson's disease, and attention-deficit hyperactivity disorder (ADHD).
  • Potential for improved efficacy of STS compared to oral selegiline formulations.
  • Previous development efforts for AD and ADHD have ceased in recent years.

Purpose of the Study:

  • To evaluate the potential of selegiline transdermal system (STS) for treating depression.
  • To assess the regulatory pathway and challenges for STS approval by the US Food and Drug Administration (FDA).

Main Methods:

  • Filing of an Investigational New Drug (IND) application for STS with the US FDA in May 2001.
  • Response to FDA feedback, including a 'non-approvable' letter received in March 2002, necessitating further efficacy data.
  • Discussions with the FDA to clarify requirements for STS approval.

Main Results:

  • The US FDA issued a 'non-approvable' letter for the STS in March 2002, citing the need for additional efficacy data.
  • Somerset engaged in discussions with the FDA to address concerns regarding the STS application.

Conclusions:

  • The development of selegiline transdermal system (STS) for depression faced regulatory hurdles requiring further efficacy validation.
  • The co-promotion agreement with Watson for selegiline in the US remains relevant to its market strategy.

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