Replies to post #182032 on Biotech Values

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Flexion Therapeutics Announces That FDA Has Removed Clinical Hold on FX006

- Company Resumes Recruitment in Pivotal Phase 2b Trial; Initiation of Phase 3 Clinical Trial Planned for Early 2015
- Conference Call Scheduled for Tomorrow, December 2, 2014 at 9:00 a.m. ET

BURLINGTON, Mass., Dec. 1, 2014 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (FLXN) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that it has lifted the clinical hold on Flexion's lead drug candidate FX006, based upon the company successfully completing the FDA's requested testing and investigation related to what was originally reported as a single case of septic arthritis of the knee. As a result, Flexion intends to immediately resume recruitment and dosing in its pivotal Phase 2b trial of FX006, and to initiate a planned Phase 3 trial in early 2015. FX006 is a first-in-class injectable, sustained-release, intra-articular steroid treatment in development for patients with moderate to severe osteoarthritis (OA) pain.

Michael Clayman, M.D., Flexion Therapeutics President and CEO, said, "We are pleased to have been able to rapidly provide data to the FDA that allowed the agency to remove the clinical hold. Now we can continue to advance FX006, which has the potential to make a real difference for the many individuals who suffer from OA pain."

On September 16, 2014, the FDA placed a clinical hold on FX006 due to a single occurrence of what was then described as an infection in the injected knee joint of a patient in the pivotal Phase 2b trial. The subsequent clinical hold letter from the FDA requested that the company:

Determine whether the study drug was the source of infection by recovering both the specific study drug vials used in the treatment of the patient who experienced the infection, as well as unused study drug vials from the clinical site where the patient was injected and test them for contamination, and
Explore other potential causes for infection, including a compromise of sterile procedures during injection.
http://finance.yahoo.com/news/flexion-therapeutics-announces-fda-removed-214848824.html