, May 6, 2014
/PRNewswire/ -- CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, has reached agreement with the U.S. Food and Drug Administration (FDA) for the planned SAMURAI study. The objective of this trial is to evaluate the safety and efficacy of two doses of Lasmiditan in comparison to placebo for the treatment of acute migraine. Patients with risk factors for cardiovascular disease will be included in the study.
The SPA agreement includes two novel endpoints for the approval of acute migraine therapiesa primary endpoint of the proportion of patients who are free of headache pain at 2 hours and a key secondary endpoint of the proportion of patients who no longer suffer from their most bothersome associated symptom of migraine (nausea, photophobia, phonophobia) at 2 hours.
"This agreement between CoLucid and the FDA clearly defines a feasible path for the development of Lasmiditan," said Thomas P. Mathers, CoLucid's chief executive officer. "We are very pleased that the FDA has agreed to the study design and planned analysis, particularly the use of two novel regulatory endpoints which are of key importance for migraine patients -elimination of headache pain and the associated symptom that is most bothersome for that particular migraine patient."
ABOUT SPECIAL PROTOCOL ASSESSMENTS
A Special Protocol Assessment is a written agreement with the FDA on the details of the design and planned analysis for a clinical trial. It is intended to form the basis for a marketing application and may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of new scientific or public health concerns before approval of an NDA. FDA's determinations for marketing application approval are made after a complete review of marketing application and are based on the entire data in the application.
Lasmiditan has been designed to deliver efficacy in acute migraine without the vasoconstrictor activity associated with previous generations of migraine therapies. It selectively targets 5-HT1Freceptors expressed in the trigeminal pathway. Its novel chemical class and differentiated site and mechanism of action led to Lasmiditan's designation as a "ditan," a new drug class, by the INN and USAN.
CoLucid has successfully completed six clinical studies for Lasmiditan, including a Phase 2b study treating a single migraine attack in 391 patients, as well as a TQTc study.
Phase 3 development will address major unmet needs in patients who are poorly served by currently available therapies to include patients with risk factors for cardiovascular disease who may not be able to take triptans.
Migraine is ranked as the seventh highest cause of global disability and in the top 10 causes of disability in 14 of 21 world regions studied, according to findings by the Global Burden of Disease Survey 2010 conducted by the World Health Organization. It is the leading cause of disability among neurological disorders. Some 36 million Americans have migraine, more than have asthma or diabetes combined. Migraine can be extremely disabling and costly, accounting for more than $20 billion in direct (e.g. doctor visits, medications) and indirect (e.g. missed work, lost productivity) expenses each year in the United States.
ABOUT COLUCID PHARMACEUTICALS, INC.
CoLucid was founded in 2005 by Pappas Ventures to advance innovative drug candidates with the potential to provide safe and effective treatments for CNS disorders. The company's investors include Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures.
CoLucid is partnered with ILDONG Pharmaceutical Co, Ltd, under a distribution and supply agreement for Lasmiditan, in South Korea and Southeast Asia.
For more information, please visit CoLucid at www.colucid.com.
SOURCE CoLucid Pharmaceuticals, Inc.