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:5/15/2017)... PHILADELPHIA , May 15, 2017 Enterin Inc., ... and developing novel compounds to treat Parkinson,s disease ... The study is a Phase 1/2a randomized, controlled, multicenter study ... sites. It will enroll 50 patients over a 9-to-12-month period. ... doses in 10 patients with PD. Participating sites include ...
(Date:5/10/2017)... WASHINGTON , May 10, 2017  The ... doctors or employees of sleep therapy clinics to ... a sleep therapy clinic is involved in a ... as interested in hearing from an employee of ... involved in a kickback scheme to provide medical practice ...
(Date:5/9/2017)... , May 9, 2017  Oramed Pharmaceuticals ... ), a clinical-stage pharmaceutical company focused on the ... that the Canadian Intellectual Property Office has granted ... Oral Administration of Exenatide". The patent covers Oramed,s ... GLP-1 is an incretin hormone that ...
Breaking Medicine Technology:
(Date:5/26/2017)... New York, NY (PRWEB) , ... May 26, 2017 , ... ... "Skin Health & Wound Care" campaign in USA Today, which will educate readers on ... Health side of the campaign, a large focus is placed on melanoma. Dancing with ...
(Date:5/26/2017)... ... May 26, 2017 , ... ... CareFusion NOX-T3 portable sleep monitor with its Somnoware Sleep Device Interface (SDI). Somnoware ... for diagnostic device operations. With this platform, initializing devices and importing studies are ...
(Date:5/26/2017)... ... May 26, 2017 , ... After raising nearly $30,000 on Kickstarter ... to be available at a discounted crowdfunding price on Indiegogo . , “Along ... I also wanted to bring a fidget toy to the market that was made ...
(Date:5/26/2017)... ... May 26, 2017 , ... “When the Stars Lead Home”: a poignant ... of published author Laura Weigel Douglas, an avid reader who lives in the Pacific ... sometimes feels like Green Hills Adventure Camp. She couldn’t be more grateful. , Twelve-year ...
(Date:5/26/2017)... , ... May 26, 2017 , ... Water damage to ... New Jersey School District had left education officials with a number of critical issues ... of the flooring had to be accomplished with little or no disruption to class ...
Breaking Medicine News(10 mins):