FDA, Clinical Trial News: Forest Labs, Nycomed, NexMed

After the market close, Forest Labs (NYSE:FRX) and privately held Nycomed announced that a Complete Response Letter (CRL) was issued by the FDA for DAXAS (roflumilast) (a once-daily oral treatment) (PDE4 Enzyme Inhibitor). The NDA is seeking FDA approval as treatment to reduce chronic obstructive pulmonary disease (COPD) exacerbations associated with chronic bronchitis in patients at risk for exacerbations and no new studies were required by the Agency with an expected response from the companies during 3Q10 to address the request for additional information and analyses.

Nycomed has partnered the drug with Merck (NYSE:MRK) in Canada and select European countries and received a positive opinion for approval  in Europe for use as add-on therapy, with an original filing date of May 2009.

In other after-hours news, NexMed (NASDAQ:NEXM) announced that a pre-IND meeting is planned for mid-July with the FDA to discussed a proposed Phase II/III clinical trial protocol evaluating a topical formulation of alprostadil (prostaglandin E1 or PGE1) for the treatment of Raynaud’s syndrome (decreased blood flow to fingers or toes).

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