The Food and Drug Administration (FDA) Office of New Drugs (OND) today notified Fabre-Kramer Pharmaceuticals (Fabre-Kramer) that it has granted its appeal pursuant to the agency’s Formal Dispute Resolution (FDR) process and concluded that Travivo demonstrates substantial evidence of effectiveness in the treatment of Major Depressive Disorder (MDD). This decision overturns FDA’s previous position reached at a lower level and clears the path toward approval for Travivo, an antidepressant with a unique mechanism of action and a favorable side effect profile.OND Director John Jenkins, M.D., stated, “After considering all the data and analyses I conclude that Fabre-Kramer has provided data to support a finding of substantial evidence of effectiveness for gepirone in the short-term treatment of MDD.” Citing the two strongly positive trials with effect sizes similar to FDA-approved antidepressants and acknowledging that antidepressants are not all equally effective, he added that “there is value in providing prescribers and patients with a wide range of effective options for use in clinical practice.”
In his finding, Dr. Jenkins said he gave careful review to the materials Fabre-Kramer submitted, as well as other reviews, meeting minutes, decision memoranda prepared by the FDA, and other pertinent materials and included consultations with staff including Lisa LaVange, PhD., FDA’s Center for Drug Evaluation and Research (CDER) Director of the Division of Biostatistics, who conducted a statistical review of the results of the Travivo Phase III program as part of the FDR process. Dr. Jenkins also convened and attended a meeting of the Psychopharmacologic Drugs Advisory Committee to review the Travivo application and carefully reviewed the detailed transcript.
Fabre-Kramer CEO Stephen Kramer, M.D. said, “We have been working diligently toward this goal and we are extremely pleased and gratified by Dr. Jenkins’ decision. We applaud him and his staff for their extraordinary care and skill in the thorough and objective review of all of the relevant data and supporting material to reach this conclusion. It opens the door to the availability of the first truly novel antidepressant in many years which has the potential to benefit millions of depressed patients. We look forward to working with the agency on next steps.”
Although the decision is subject to a possible internal review, Fabre-Kramer is confident the OND ruling will be upheld. The efficacy issue addressed by Dr. Jenkins’ decision resolves the only non-approval deficiencies cited in the Agency’s earlier decision letter. Fabre-Kramer will meet with CDER’s Division of Psychiatry Products to discuss remaining details to be addressed prior to resubmission of the NDA. Once resubmitted, FDA will have six months under PDUFA to review the amended NDA and reach a decision.
Dr. Stephen Stahl, Professor of Psychiatry, University of California and founder of the Neuroscience Education Institute said, “Travivo is a standout drug that offers a truly unique mechanism compared to current therapies on the market and it’s an important addition to the armamentarium to treat depression. What’s more, the FDA’s decision today will have a positive effect on the future development of drugs in this class.”
Studied in over 5,000 patients, Travivo has been found to have a favorable safety profile and be well-tolerated. The drug’s unique single mechanism of targeted 5HT1a agonism, allows for the relief of depressive symptoms without significant side effects. The most frequent adverse events seen in clinical trials were lightheadedness and nausea, which generally were mild, of short duration, and related to dose escalations. Adverse event data from all trials, as well as sexual functioning data collected using standardized scales in numerous Travivo trials, indicate that Travivo does not cause sexual dysfunction in depressed patients, a common side effect among most available anti-depression therapies.
Source: Travivo
Filed Under: Drug Discovery
