While pending FDA new product decisions are never a sure thing, BioDelivery Sciences (BDSI) appears to have the odds stacked in its favor for approval of cancer breakthrough pain drug candidate Onsolis.

BDSI submitted a Risk Evaluation and Mitigation Strategy (REMS) for Onsolis (BEMA fentanyl) based on the feedback it received from a complete response ruling by the FDA last August. Since the FDA has informed BDSI that all other aspects of the NDA review are complete, the prospects for Onsolis approval are excellent, with an approval decision possible by mid-June based on a Class II (six-month) review by the agency on the re-submission.

The FDA issued a statement last month directed at drug makers which market the strongest types of painkillers - classified as opiates which are highly regulated as DEA Class 2 Controlled Substances. The FDA wants pain drug makers to play a larger role in stemming abuse and diversion issues amidst concern about the rising incidence of overdose deaths, abuse, misuse, and diversion associated with opiates such as Duragesic (fentanyl patches), OxyContin, and similar drugs.

King Pharma (KG) is most affected by the FDA policy statement on narcotic pain drugs since it is developing Remoxy, Acurox, and Embeda as three opiate painkillers designed to reduce the risk of abuse and misuse. Pain Therapeutics (PTIE) and King received a complete response for Remoxy in December while King acquired Embeda with its Alpharma acquisition, but the FDA has not issued a decision on the latter NDA. Earlier this week, King and partner Acura Pharma (ACUR) announced that the NDA for Acurox was accepted by the FDA with a priority review (six-month) designation.

The CEO of Meda, Anders Lonner, expects Onsolis to generate "well over $200M" in peak annual sales within the breakthrough cancer pain market, thanks to its sales force of over 400 reps in the U.S., including coverage of specialists who focus on pain management. BDSI expects to generate positive cash flow from operations this year with approval of Onsolis likely by mid-2009 and the remaining $27M due upon FDA approval is a significant catalyst by itself given the Company's current market cap of $54M.

BDSI also has two compounds in Phase 2 clinical development, including BEMA Buprenorphine and Bioral Amphotericin B (Ampho B). Buprenorphine is a DEA Schedule 3 Controlled Substance, which is also a pain drug currently marketed in injectable (IV), sublingual (SL), and transdermal (skin patch) formulations.

Buprenoprhine offers the potential for less opiate side effects (e.g. constipation, respiratory depression) and has less potential for abuse (resulting in a Schedule 3 classification rather than the more stringent Class 2 drugs which are not eligible for refills versus other controlled drugs which can be refilled up to five times in a six month period).

BDSI plans to initiate a pair of Phase 2 clinical trials during 2Q09 (dental pain study) and 3Q09 (osteoarthritis pain study). Phase 3 clinical development is projected to occur next year during 1Q10, and BDSI also expects to sign a licensing deal at this time with the goal of a NDA submission to the FDA in the first half of 2011.

Bioral Ampho B is being developed as a fungicidal agent (a treatment for fungal infections which kills the cause rather than existing fungistatic oral treatments which merely inhibit fungal growth and reproduction) which offers the potential for better treatment outcomes, including less hospitalizations or earlier discharge of inpatients compared to the existing intravenous (IV) formulation of Ampho B. Bioral Ampho B will be evaluated in additional Phase 1 clinical trials during 2Q09 while Phase 2 clinical trials are expected to begin next year. Phase 3 clinical development is projected for 2011, with the goal of signing a licensing agreement by early next year.

With about 19M shares of common stock outstanding and a market cap of $54M, BDSI is set for a big year if it receives FDA approval for Onsolis, with the potential to generate $40M in revenue and positive cash flow from operations during 2009. Since the FDA has informed BDSI that all other aspects of the NDA review are complete, the prospects for Onsolis approval are excellent with just the REMS remaining for the agency to review. Also, the targeted inpatient population of cancer breakthrough pain patients decreases the chance for abuse and diversion of the drug compared to treatments which target the general population.

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