Catalyst
Slingshot members are tracking this event:
Flamel Technologies(FLML) plans to meet with the FDA to discuss the development plan for FT227 by the end of the year
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Additional Information
We feel our time is best served focusing on projects which are further down the clinical pathway. In addition to positive data read-out [ph] for Medusa, we received feedback from the FDA regarding the clinical development pathway for FT227, an abuse-deterrent, extended-release, oral hydromorphone product using our proprietary Trigger Lock drug delivery platform.Following this guidance from FDA we will be conducting an in vivo alcohol interaction study during the third quarter of 2016, which should provide further confirmation of the robust abuse-deterrent capabilities of Trigger Lock. Although we have already started discussions to out-license this technology for use across all opioids, we believe the alcohol interaction study will strengthen our prospects of the successful deal. To-date the Company has completed two pharmacokinetic studies of FT227 in 30 healthy volunteers. In addition to an independent in vitro study confirming FT227's superior resistance to extraction/recovery in various media under several different conditions as compared to both Exalgo and Oxycontin.
Slingshot Insights Explained
Catalyst Date
Occurred on:
Aug 08, 2016
Occurred Source:
http://seekingalpha.com/article/3997401-flamel-technologies-flml-ceo-mike-anderson-q2-2016-results-earnings-call-transcript?part=single
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Related Keywords
Abuse Deterrent, Ft227, Hydromorphone, Trigger Lock Drug Delivery Platform
