Avanir Docosanol 10% Cold Sore Cream OTC Approval Expected By Firm
This article was originally published in The Tan Sheet
Executive Summary
Avanir Pharmaceuticals expects to launch direct-to-OTC a docosanol 10% cream as a treatment for recurrent oral-facial herpes in the first or second quarter of 2000. The firm currently has no products on the market and is considering whether to sell the cream alone or with a partner.
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Avanir Pharmaceuticals expects to launch direct-to-OTC a docosanol 10% cream as a treatment for recurrent oral-facial herpes in the first or second quarter of 2000. The firm currently has no products on the market and is considering whether to sell the cream alone or with a partner. Avanir originally applied to market the product as a prescription drug but received two "not approvable" letters. According to the company, in its appeal of FDA's decision, FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, said in a teleconference the NDA should be considered as an OTC product in part because the cream is more effective when applied at the first symptoms of an outbreak. Avanir said Woodcock also stated the company's clinical effectiveness data were adequate for approval pending an audit of the data from one European study. The other condition for approval is to reach agreement with the agency on labeling. Avanir received its first "not approvable" letter in December 1998 and submitted its amended NDA in March. It received a second letter in September stating the data were not sufficient to establish effectiveness for treatment of cold sores or fever blisters. Subsequently, the firm decided to find a pharmaceutical development or marketing partner to either perform the additional clinical trial needed and market the drug when approved or market a reformulated version taken directly OTC, Avanir explained in an Oct. 4 filing with the Securities & Exchange Commission. Avanir has held meetings with interested firms but has not announced an agreement. Cold sore preparations on the market include Del Labs' Orajel Mouth-Aid for Canker and Cold Sores (benzocaine 20%, benzalkonium chloride .02%, zinc chloride .1%), Orajel CoverMed Fever Blister/Cold Sore Treatment Cream and Tanac Medicated Gel, both with dyclonine hydrochloride 1% and allantoin .5%; J.B. Williams' Cepacol Viractin Cold Sore Treatment Cream and Gel (tetracaine 2%); and Zila Pharmaceutical's Zilactin Medicated Gel (benzyl alcohol 10%), Zilactin-L Liquid (lidocaine 2.5%) and Zilactin-B Medicated Gel (benzocaine 10%). |