Office of New Drugs Director John Jenkins M.D. will review Gepirone data and analysis

Fabre-Kramer Looks Forward to FDA’s Decision on Gepirone ER for the Treatment of Major Depressive Disorder

SILVER SPRING, Md. and HOUSTON, Dec. 2, 2015 (View release on PRNewswire.com)

— Fabre-Kramer Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) completed its review of gepirone ER for the treatment of major depressive disorder (MDD) and that the input from the committee will be considered by Dr. John Jenkins, the Director of the Office of New Drugs at the Center for Drug Evaluation and Research at FDA. Fabre-Kramer remains cautiously optimistic based on the discussion at the PDAC today.

Dr. Lisa LaVange, Director of the Office of Biostatistics at the FDA’s Center for Drug Evaluation and Research, presented an assessment in the meeting that is consistent with Fabre-Kramer’s – that gepirone has demonstrated substantial evidence of effectiveness. It was also echoed by several panel members who possess extensive experience in depression.

The advisory committee as a whole expressed overwhelming support for the safety of the product. In addition, the current standing members of PDAC, as well as the acting chairman, voted favorably regarding the benefit risk of gepirone in the treatment of MDD.

“We are encouraged by the universal agreement by the FDA and PDAC that there are two adequate, well-controlled studies supporting the effectiveness of this product, and by Dr. LaVange’s conclusion that the totality of the evidence also supports effectiveness,” said Dr. Stephen J. Kramer, CEO of Fabre-Kramer. “We’re optimistic the FDA will determine gepirone to be effective, as they have done for all other products in this class with two positive studies.”

There were multiple pleas for broader access to antidepressant options during the Committee’s Open Public Session, and recognition of the need for new treatments for the millions of patients with debilitating depression for whom current medications are inadequate.

“Gepirone ER is a drug with a novel mechanism that promises to work for patients where other drugs don’t,” said Dr. Stephen Stahl, Professor of Psychiatry, University of California and founder of the Neuroscience Education Institute.

During the discussion, certain committee members suggested the potential need for a third positive study, beyond the traditional standard for approval of drugs, to counterbalance the number of failed/negative studies and provide further reassurance of the drug’s efficacy.

“There’s more at stake here than just gepirone,” commented Dr. Stahl. “The larger concern is that if the FDA does not approve this drug, it will discourage companies from trying to create new psychiatric drugs, which many companies already avoid because of the high failure rate. It could have a chilling effect on future development in this class.”

“We await the decision of the FDA, and remain hopeful they will conclude gepirone ER has demonstrated substantial evidence of effectiveness, clearing the way for the availability of this new treatment for MDD for the benefit of both patients and physicians,” said Dr. Kramer.

About Gepirone ER
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 such as sexual dysfunction that limit their use. Gepirone ER 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. The company’s leadership has a long history in clinical research and an impressive track record of the clinical development of more than 17 psychiatric drugs approved in the U.S.