CORAL GABLES, Fla., Oct. 27, 2015 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced that Barbara Coffey, MD, MS, Chief, Tics and Tourette’s Clinical and Research Program, Icahn School of Medicine at Mount Sinai, will present a poster at the 62nd Annual Meeting of the American Academy of Child and Adolescent Psychiatry being held at the Henry B. Gonzalez Convention Center in San Antonio, Texas from October 26-31. The poster, entitled, “Vigabatrin in Patients with Treatment-Resistant Tourette's Disorder: A Proof-of-Concept Study”, (Poster # NRPOSTER-2.23) will be presented at the conference from 10:00 am to 12:30 pm CDT on October 29th. The poster will be posted at www.catalystpharma.com in the Investors section under Events & Presentations.
The poster presents preliminary data on safety and effectiveness obtained from a proof-of-concept, 8-week, open-label trial evaluating CPP-109 (vigabatrin) in patients with Treatment-Refractory Tourette's Disorder conducted by Dr. Coffey, in collaboration with Dr. Jonathan D. Brodie at the NYU Langone Medical Center, the Co-Principal Investigator and lead inventor of this use of GABA-AT inhibitors. The trial was designed to evaluate the potential effect of GABA-aminotransferase inhibition by vigabatrin as a mechanism for reducing tics in subjects at least 18 years of age with a DSM-IV-TR diagnosis of Tourette's Disorder, who exhibited unsatisfactory response to all prior treatments.
Vigabatrin was used as a "research surrogate" to demonstrate the utility of GABA-aminotransferase (GABA-AT) blockade, with the expectation that upon successfully demonstrating the utility of this mechanism, further development activities would focus on the potentially safer, more potent GABA-AT inhibitor, CPP-115. In addition, Catalyst is developing a generic equivalent of Sabril® (vigabatrin).
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), infantile spasms, and Tourette's Disorder. Catalyst's lead candidate, Firdapse® for the treatment of LEMS, recently completed testing in a global, multi-center, pivotal Phase 3 trial resulting in positive top-line data. Firdapse for the treatment of LEMS has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and orphan drug designation for LEMS and CMS. Firdapse is the first and only European approved drug for symptomatic treatment in adults with LEMS.
Catalyst is also developing CPP-115 to treat infantile spasms, epilepsy and other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder and Tourette's Disorder. CPP-115 has been granted U.S. orphan drug designation for the treatment of infantile spasms by the FDA and has been granted E.U. orphan medicinal product designation for the treatment of West Syndrome by the European Commission.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including whether the receipt of breakthrough therapy designation for Firdapse will expedite the development and review of Firdapse by the FDA or the likelihood that the product will be found to be safe and effective, what clinical trials and studies will be required before Catalyst can submit an NDA for Firdapse for the treatment of CMS and whether any such required clinical trials and studies will be successful, whether an NDA for Firdapse will ever be accepted for filing by the FDA, the timing of any such NDA filing or acceptance, whether, if an NDA for Firdapse® is accepted for filing, such NDA will be given a priority review by the FDA, whether Catalyst will be the first company to receive approval for amifampridine (3,4-DAP), giving it 7-year marketing exclusivity for its product, whether CPP-115 will be determined to be safe for humans, whether CPP-115 will be determined to be effective for the treatment of infantile spasm, post-traumatic stress disorder, Tourette's Disorder or any other indications, whether Catalyst can successfully design and complete a bioequivalence study of its version of vigabatrin compared to Sabril that is acceptable to the FDA, whether any such bioequivalence study the design of which is acceptable to the FDA will be successful, whether any ANDA that Catalyst files for a generic version of Sabril will be accepted for filing, whether any ANDA for Sabril accepted for filing by the FDA will be approved (and the timing of any such approval),whether any of Catalyst's product candidates will ever be approved for commercialization or successfully commercialized, and those other factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2014 and its other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.