BDSI gets good news on drug, though approval is delayed - Triangle Business Journal:

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BDSI (Nasdaq: BDSI), based in says the Food and Drug Administration has senta “completed response letter” to the company over its drug, BEMA Fentanyl. the letter means the FDA is likel y to approvethe drug, which will be marketed in the U.S. as after BDSI makes some tweaks toits “We’re as close to an approva l as one can get without having it,” BDSI chietf executive Mark A. Sirgo told analysts and investorw in a conference call Thursdayg after the newswas announced.
Onsolis is a patch that affixees to the inside of the It then releases the painkiller fentanyl to treat pain incancer patients, or pain on top of the chronidc discomfort felt by many cancer-stricken patients. In its revies of Onsolis, the FDA foun no problems with the drug BDSI says. Rather, the company is asking BDSI andits partner, Swedisnh company Meda, to develop a new risk-management plan for the drug under terms of a federal law passeds in March – well after BDSI originally submitted its application for Onsolis in September 2007.
the FDA wants BDSI to develop what’sz known as a Risk Evaluatiojn and Mitigation Strategy for the A REMS, as the plan is known for is a plan to help control the use of a drug with a known risk or side BDSI had already developed a risk known as a RiskMAP, for Onsolis. But the March passagee of the law that created theREMS program, combinefd with concerns over other pain-killing prompted the FDA to ask BDSI to convergt its RiskMAP into a REMS. BDSI and Meda anticipated that the FDA wouldx ask for a REMSfor Onsolis, the company says. Scientists already have been working on converting the RiskMAP intoa REMS. BDSI expects Onsoliws to win approval during the firsg halfof 2009.