Navigation Links
CoLucid Pharmaceuticals Details Phase 3 Development Strategy for Lasmiditan to Address Major Unmet Needs in Acute Migraine Therapy
Date:9/18/2012

DURHAM, N.C., Sept. 18, 2012 /PRNewswire/ -- CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, has reached agreement with the Food and Drug Administration's Division of Neurology Products concerning the development strategy for lasmiditan at a recently completed End of Phase 2 meeting. Lasmiditan is a novel therapy for acute migraine and will initially be developed to address major unmet needs in two patient populations who are poorly served by currently available therapies:  1) patients with risk factors for cardiovascular disease and those with diagnosed cardiovascular disease and 2) patients who have not had adequate efficacy from triptans.  The development program will be confirmed via the Special Protocol Assessment process.

Lasmiditan is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies such as triptans.  Lasmiditan is a member of a novel chemical class called "ditans" and, unlike triptans, penetrates the central nervous system (CNS) and selectively targets receptors expressed in the trigeminal pathway.  Lasmiditan does not interact with vasoconstrictor receptors on peripheral blood vessels which are activated by triptans.

CoLucid has further evaluated lasmiditan's cardiovascular profile by recently completing a Thorough QT/QTc study (TQT) titled COL MIG-105: A Randomized, Double-blind, Placebo-controlled, 4-way Crossover Study to Compare the Effects on the Cardiac De- and Re-polarization Duration as well as other Cardiac Safety Parameters of Two Doses of Oral Lasmiditan (100 mg and 400 mg) with those of Moxifloxacin (400 mg) and Placebo in Healthy Subjects.  The statistical evaluation of the primary variable revealed that lasmiditan caused no significant QT prolongation either at 100 mg (the putative therapeutic dose) or at 400 mg (supratherapeutic dose), whereas moxifloxacin caused a QT prolonging effect similar to that seen in published studies and thus assay sensitivity for this study was demonstrated. No pro-arrhythmic effect of lasmiditan was observed in the assessments of ECGs made by a cardiologist, and safety and tolerability were similar to observations in previous studies.

"We believe that lasmiditan's unique central mechanism of action provides acute migraine relief without the associated chest symptoms and vasoconstrictor effects seen with triptans. Lasmiditan could be a very important treatment for those patients who are warned not to take triptans, such as patients with high blood pressure or high cholesterol, obese patients or those with diabetes, smokers and patients with a strong family history of coronary artery disease, post-menopausal women or men over 40 years of age," commented Thomas P. Mathers, Chief Executive Officer. "There are a large number of acute migraine patients who do not respond to triptan therapy. Lasmiditan could provide an excellent therapeutic alternative for these patients who now frequently turn to opioids."

About Lasmiditan

Six clinical studies have been successfully completed, including a Phase 2b double blind placebo controlled oral dose ranging study treating a single migraine attack. 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 secondary endpoints, including relief of nausea, photophobia and phonophobia.  Importantly, because there was no evidence of drug-related cardiovascular effects or chest symptoms in the previous six clinical studies, CoLucid expects that the pivotal Phase 3 studies will confirm that lasmiditan's side effect profile is highly differentiated from triptans and ergotamines.

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. For more information, please visit CoLucid at www.colucid.com.

 


'/>"/>
SOURCE CoLucid Pharmaceuticals, Inc
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
2. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
3. Nouveau Life Pharmaceuticals (HRID) Contracts with U.S. Manufacturer to Produce New Female Supplement
4. BioElectronics Survey Indicates a Five-Fold Superior Pain Relief Compared to OTC Pharmaceuticals
5. Icahn Issues Statement Regarding Amylin Pharmaceuticals
6. Almost 50 Percent of the Glaucoma Patient Population Remains Untreated, Signifying a Vast Market for Glaucoma Pharmaceuticals, Finds Frost & Sullivan
7. Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
8. Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
9. Jazz Pharmaceuticals Announces First Quarter 2012 Financial Results Conference Call On May 8, 2012
10. Inovio Pharmaceuticals Granted U.S. Patent Protection for Synthetic Vaccine for Cervical Dysplasia and Cancer
11. Avanir Pharmaceuticals To Present at Three Conferences In May
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/7/2017)... --  Provista, a proven leader in the supply ... power, today announced a new resource area on Provistaco.com ... is the online home for case studies, articles on ... releases, slideshows and events. ... at their fingertips, viewers can also watch short videos ...
(Date:10/2/2017)... Mich. , Oct. 2, 2017 Diplomat ... 8th Day Software and Consulting, LLC , and ... 8th Day Software, based in Tennessee ... LLC. 8th Day expands EnvoyHealth,s service offerings for health ... development. "In an ...
(Date:9/28/2017)... Hill-Rom Holdings, Inc. (NYSE: HRC), will host its fiscal ... Friday, November 3, 2017, beginning at 7:00 a.m. (CDT) ... a.m. (CDT) / 9:30 a.m. (EDT). In ... guidance for 2018, Hill-Rom executives will also highlight the ... long-range financial outlook through 2020. ...
Breaking Medicine Technology:
(Date:10/13/2017)... , ... October 13, 2017 , ... ... and Agile Software Development, has been awarded a contract by the Center for ... Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in a ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare Compliance ... management, will showcase a range of technology and learning solutions at the 68th ... and Expo to be held October 14–18, 2017 at the Mandalay Bay Resort ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company ... of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every ... meet the highest standard. , These products are also: Gluten Free, Non-GMO, ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally ... care, have expanded their existing home health joint venture through an agreement, effective ... operating a joint venture home health company with Asante, delivering clinically integrated care, ...
(Date:10/12/2017)... PA (PRWEB) , ... October 12, 2017 , ... ... is the recipient of a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B ... York City on October 11, 2017. , The annual award competition recognizes editorial and ...
Breaking Medicine News(10 mins):