Navigation Links
CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine
Date:8/18/2011

DURHAM, N.C., Aug. 18, 2011 /PRNewswire-iReach/ -- Durham, NC, August 18, 2011 /PRNewswire/ -- CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced today that it has received clearance to proceed with clinical studies of lasmiditan (formerly known as COL-144) under IND 103,420 from the Food and Drug Administration (FDA).

Lasmiditan is a first-in-class oral tablet formulation of a Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies.  Lasmiditan is a member of a novel chemical class called "ditans", and, unlike triptans, which target vasoconstrictor 5-HT1B receptors, lasmiditan penetrates the central nervous system (CNS) and selectively targets 5-HT1F receptors expressed in the trigeminal nerve pathway.

Five clinical studies have been successfully completed outside of the U.S., including a Phase 2b double blind placebo controlled dose ranging study treating a single migraine attack which was completed in 2010. In the Phase 2b study, lasmiditan achieved its primary endpoint of reducing a moderate or severe headache at baseline to mild or none 2 hours after dosing (p<0.0001) in 391 patients. Differentiation of individual doses from placebo was seen as early as 30 minutes after dosing. Lasmiditan also achieved numerous secondary endpoints per other migraine symptoms such as nausea, photophobia and phonophobia.  Importantly, lasmiditan's side effect profile is highly differentiated from triptans and ergotamines, and there was no evidence of drug-related cardiovascular effects or chest symptoms in the previous five clinical studies.

"The migraine market, estimated at 30 million sufferers in the US, is an under-served market.  No new class of therapies has been introduced for the treatment of acute migraine since the triptan class, which was first launched almost 20 years ago," remarked Thomas P. Mathers, Chief Executive Officer of CoLucid.  "Patient and physician feedback note that only a portion of migraine patients are adequately controlled on triptans, and patients would welcome a new product that could offer a rapid speed of onset, superior pain relief and/or a lack of cardiovascular side effects as compared to currently available products.  In addition, due to their vasoconstrictor activity, triptans are contraindicated in patients with cardiovascular disease.  Many neurologists and primary care physicians feel uncomfortable prescribing triptans because of their potential cardiovascular side effects.  Lasmiditan may address these unmet needs with its novel mechanism of action, and we look forward to the results of the Phase 3 trials to confirm its rapid speed of onset, superior pain relief and lack of cardiovascular side effects," said Mr. Mathers.

The Company is speaking with potential partners and is interacting with the FDA, and plans to advance lasmiditan into Phase 3 development.

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. The company's pipeline includes lasmiditan, 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: Kathy Kelly CoLucid Pharmaceuticals, Inc., 919-806-4304, kkelly@colucid.com


'/>"/>
SOURCE CoLucid Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. CoLucid Appoints Thomas P. Mathers as Chief Executive Officer
2. Valeant Pharmaceuticals Announces Resignation of Michael Van Every From Valeants Board of Directors
3. Endo Pharmaceuticals Announces Termination of Collaboration with Grunenthal for the Development of Axomadol
4. Savient Pharmaceuticals Announces Publication of Pivotal Phase III KRYSTEXXA® Data in JAMA Demonstrating Significant Benefits in Refractory Chronic Gout Patients
5. Access Pharmaceuticals Provides Second Quarter Update on MuGard Commercial Activities
6. Janssen Pharmaceuticals, Inc. Launches Online Tools on PrescribeResponsibly.com
7. Lotus Pharmaceuticals Announces Second Quarter Fiscal 2011 Financial Results
8. Omthera Pharmaceuticals, Inc. Initiates Phase III ESPRIT Trial of Add-on Epanova™ to Statin Therapy in Patients with Hypertriglyceridemia
9. Pacira Pharmaceuticals, Inc. to Present at Wedbush Securities 2011 Life Sciences Management Access Conference
10. Robert Hoffman to Rejoin Arena Pharmaceuticals as Vice President, Finance and Chief Financial Officer
11. Lexicon Pharmaceuticals to Present at the Wedbush 2011 Life Sciences Management Access Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/5/2016)... 2016  Balloon catheter is an innovative medical device ... the femoral artery in the leg or sometimes into ... blood vessels. These products are generally used to prevent ... of lipid substances in the blood vessel. In terms ... to expand at a CAGR of 3.8% during the ...
(Date:12/5/2016)... Kingdom , Dec. 5, 2016   Mallinckrodt ... global specialty pharmaceutical company, today announced that it received ... Corporate Equality Index (CEI), a national benchmarking survey and ... gay, bisexual and transgender (LGBT) workplace equality, administered by ... ranks of 517 major U.S. businesses which also earned ...
(Date:12/5/2016)...  Parallax Health Sciences, Inc. ("Parallax" or the "Company") ... pharmaceutical business, RoxSan Pharmacy, Inc. has received a license ... of the 42 states it is currently licensed to ... Pharm . D, Pharmacist in Charge at RoxSan Pharmacy, ... Medicare B spending last year came to roughly $170 ...
Breaking Medicine Technology:
(Date:12/6/2016)... ... December 06, 2016 , ... SPH ... firms. The ranking is based on reported data for 2015 performance and ... systems, ambulatory surgical centers, clinically integrated networks, and many of the nation’s leading ...
(Date:12/6/2016)... ... 06, 2016 , ... The Behavioral Health Center of Excellence ... organization as a top behavioral service provider in the country. The award celebrates ... satisfaction and qualifications, and consumer satisfaction. These areas are measured via a wide-ranging ...
(Date:12/6/2016)... ... December 06, 2016 , ... Just in time for the holiday season, ... chip cookie recipe for Honeyville’s new Organic Quinoa Flour product for sale at Costco ... the near future. , “I think it’s wonderful that a growing number of ...
(Date:12/6/2016)... ... ... Keeping Gift Season Safe, In a season stacked with gift-giving opportunities, it's ... recipients. This is the idea behind Safe Toys and Gifts Month, which sets aside ... good gifts for children. For companies that produce goods that fall into this category, ...
(Date:12/6/2016)... Viejo, California (PRWEB) , ... December 06, 2016 , ... ... allows users to flicker, flash, and flare from clip to clip with high quality ... , TransFlare 4K Jewel contains 44 lens flares filmed on the RED Dragon. ...
Breaking Medicine News(10 mins):