Migraine Talk
Would you like to react to this message? Create an account in a few clicks or log in to continue.

CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine

3 posters

Go down

CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine Empty CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine

Post by Tee Fri Aug 19, 2011 3:45 am

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.

http://www.prnewswire.com/news-releases/colucid-pharmaceuticals-receives-clearance-for-investigational-new-drug-ind-application-for-lasmiditan-for-the-treatment-of-acute-migraine-127998763.html
Tee
Tee
Admin

Posts : 1887
Join date : 2011-04-14
Age : 53
Location : Whitstable, Kent

https://migrainetalk.forumotion.co.uk

Back to top Go down

CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine Empty Re: CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine

Post by akrohn Fri Aug 19, 2011 7:32 am

Here's hoping this one is safe! We could use another medication that works.
akrohn
akrohn

Posts : 45
Join date : 2011-07-22
Age : 50
Location : Salisbury, NC, USA

Back to top Go down

CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine Empty Re: CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine

Post by Tee Sat Aug 20, 2011 3:58 am

I do like the sound of this one - as it claims to provide relief without the cardiovascular side effects associated with triptans. Lasmiditan, part of a chemical class called “ditans,” more selectively targets the receptors that trigger migraines...... lets hope they get good results with the new trails Smile
Tee
Tee
Admin

Posts : 1887
Join date : 2011-04-14
Age : 53
Location : Whitstable, Kent

https://migrainetalk.forumotion.co.uk

Back to top Go down

CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine Empty Re: CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine

Post by whitzendJane Sat Aug 20, 2011 5:57 am

so I am assuming it's an abortive?
whitzendJane
whitzendJane
Admin

Posts : 358
Join date : 2011-04-14

Back to top Go down

CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine Empty Re: CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine

Post by Tee Sat Aug 20, 2011 7:47 am

Yes - It looks like it.......... just needed them to make a good preventative now Smile
Tee
Tee
Admin

Posts : 1887
Join date : 2011-04-14
Age : 53
Location : Whitstable, Kent

https://migrainetalk.forumotion.co.uk

Back to top Go down

CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine Empty Re: CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine

Post by Sponsored content


Sponsored content


Back to top Go down

Back to top

- Similar topics

 
Permissions in this forum:
You cannot reply to topics in this forum