CoLucid Pharmaceuticals, Inc. Announces Study Data Documenting Oral Efficacy of Lasmiditan (COL-144), a Selective 5-HT1F Receptor Agonist, in the Treatment of Acute Migraine Attacks
DURHAM, N.C., June 9 /PRNewswire/ -- CoLucid Pharmaceuticals,
Inc., ("CoLucid"), an innovative biotechnology company focusing on
therapies for central nervous system disorders, today announced
that its investigational first-in-class Neurally Acting
Anti-Migraine Agent (NAAMA), lasmiditan (also known as COL-144), a
selective 5-HT1F receptor agonist, was effective when given orally
to treat acute migraine attacks, as documented in a Phase IIb
study. Results of this study will allow the selection of doses for
pivotal Phase III studies of lasmiditan in the acute treatment of
migraine, scheduled to begin in fourth quarter this year.
"There is a high unmet need for novel migraine treatments that
are effective and safe," said James F. White, Ph.D., President and
Chief Executive Officer of CoLucid. "Currently available drugs have
varying efficacy and side effects that limit their use in patients.
Lasmiditan with its exciting new mechanism of action has the
potential to address these patient needs."
In the recently completed double blind, randomized,
placebo-controlled parallel group dose-ranging study conducted in
five European countries, 391 patients treated a single migraine
attack with one of four doses of lasmiditan or placebo. The Phase
IIb study met its primary endpoint, showing a highly significant
correlation between dose and headache relief at two hours.
Individual doses showed significant benefit compared to the placebo
from as early as 30 minutes after treatment. Lasmiditan also
provided significant relief of other migraine symptoms, as measured
in the study, including nausea, photophobia and phonophobia.
Dizziness and fatigue were the most common adverse events
reported in the study. No clinically significant adverse effects
were identified in either the laboratory parameters or
electrocardiography (ECGs). Cardiovascular adverse events,
including chest symptoms experienced with the current migraine
medication group known as triptans, were rare and occurred with
similar frequency in the placebo and active treatment groups.
The investigators intend to submit a complete Phase IIb data
analysis for peer-review publication or presentation.
Migraine is a painful neurological condition, of which the most
common symptom is an intense and disabling headache. A chronic
illness, migraine is widespread in the U.S. population (12 percent
diagnosed, 5 percent undiagnosed). In addition to being a major
cause of pain and suffering, chronic migraine attacks are a
significant source of both medical costs and lost
Migraines are often accompanied by photophobia (hypersensitivity
to light), phonophobia (hypersensitivity to sound), worsening on
movement, and nausea. Differential diagnosis requires exclusion of
other possible causes of pain, such as head injury, stroke, tumors
and tension headache.
For more information on headache causes and treatments visit
About CoLucid Pharmaceuticals, Inc.
CoLucid was founded in December 2005 by Pappas Ventures to
advance innovative drug candidates with the potential to provide
safe and effective treatment for central nervous system (CNS)
disorders. The company's investors include Pappas Ventures, Domain
Associates, Care Capital, Pearl Street Venture Funds and Triathlon
Medical Ventures. The company's pipeline includes lasmiditan
(COL-144), a novel treatment for migraine headache, and a
conjugated stigmine platform that has generated a series of
preclinical candidates for the treatment of sleep/wake disorders,
chronic pain, Alzheimer's disease and psychiatric disorders. For
more information, please visit CoLucid at www.colucid.com
Media Contact: Shirley Chow Porter Novelli Life Sciences 212-601-8308 Shirley.firstname.lastname@example.org
Source: CoLucid Pharmaceuticals, Inc.
CONTACT: Shirley Chow of Porter Novelli Life Sciences,
Shirley.email@example.com, for CoLucid Pharmaceuticals, Inc.
Web Site: http://www.colucid.com/
Posted: June 2010