Travivo™ Demonstrates Substantial Evidence of Effectiveness in Treatment of Major Depressive Disorders

FDA Rules Favorably On Efficacy Of Travivo™ (Gepirone ER) For Treatment Of Major Depressive Disorder

HOUSTON, March 17, 2016 (View release on PRNewswire.com)

Office of New Drugs’ decision overturns previous position on Fabre-Kramer Pharmaceuticals’ antidepressant with novel mechanism and minimal side effects.

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 and resolves an outstanding deficiency impeding approval of 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.”

We have been advised that a review team member has, pursuant to internal FDA procedures for dispute resolution (MaPP 4151.1), announced the intention to appeal Dr. Jenkins’ decision within the agency, which effectively “stays” the implementation of OND’s decision pending the resolution of this appeal. The CDER Director has asked that all materials relevant to her review be submitted by April 1, and she intends to make a final determination in a timely manner. Fabre-Kramer is confident that the CDER Director will uphold Dr. Jenkins’ well-reasoned conclusions.

The OND decision resolves the only non-approval deficiencies cited in the Agency’s earlier decision letter. If upheld, 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.

About Travivo
Although some effective treatment options exist for adults with MDD, drugs such as SSRIs and SNRIs are not always optimal since they are often associated with side effects including sexual dysfunction that limit their use. Travivo has been shown to effectively treat the disorder without causing sexual dysfunction and with fewer side effects than other antidepressants including transient lightheadedness and nausea.

About Fabre-Kramer
Fabre-Kramer is committed to developing and bringing to market advanced new medications to help physicians treat their patients unmet medical needs in the therapeutic areas of psychiatry and neurology. The company focuses on compounds to license-in, develop for global registration, and license-out to commercial partners. The company looks forward to discussions with potential partners to bring Travivo™ to market.

About Depression
According to the Anxiety and Depression Association of America, Major Depressive Disorder is the leading cause of disability in the U.S. for ages 15 to 44, and affects approximately 14.8 million American adults. Depression rates in the United States, and worldwide, continue to rise. Studies show that rates of depression for Americans have risen dramatically in the past 50 years. Research published in The American Journal of Psychiatry found that major depression rates for American adults increased from 3.33 percent to 7.06 percent from 1991 through 2002. Depression is also considered a worldwide epidemic, with 5 percent of the global population suffering from the condition, according to the World Health Organization.