Apricus Biosciences (APRI) Granted Request for MycoVa Type C Regulatory Guidance from FDA
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Apricus Biosciences, Inc. (Nasdaq: APRI) reports that the United States Food and Drug Administration has granted the Company's request for Type C regulatory guidance from the agency for MycoVa, the Company's topical treatment for onychomycosis, or nail fungus.
The guidance is expected to be received in late July 2012. The purpose of the requested guidance is to obtain feedback from the agency regarding the suitability of MycoVa™'s clinical and safety data to support a New Drug Approval in the U.S.
The guidance will come from the Division of Dermatology and Dental Products within the Office of New Drugs in FDA's Center for Drug Evaluation & Research. MycoVa is a topically applied formulation of terbinafine hydrochloride, a well-known medication for nail fungus, delivered with Dodecyl 2-(N, N dimethylamino)-propionate hydrochloride (DDAIP HCl), Apricus Bio's proprietary NexACT delivery technology, which enhances absorption of drugs through the skin and other barriers including the nail plate and nail bed. The Company believes MycoVa clinical trials have exhibited a significant mycological effect to eradicate the fungus and also has successfully demonstrated non-inferiority compared to Loceryl, the current topical standard of care for onychomycosis in Europe.
In addition, Apricus Bio believes the safety profile of topical terbinafine is significantly improved and much better tolerated than oral terbinafine, which is limited in use in some patients due to its potential for liver toxicity.
The guidance is expected to be received in late July 2012. The purpose of the requested guidance is to obtain feedback from the agency regarding the suitability of MycoVa™'s clinical and safety data to support a New Drug Approval in the U.S.
The guidance will come from the Division of Dermatology and Dental Products within the Office of New Drugs in FDA's Center for Drug Evaluation & Research. MycoVa is a topically applied formulation of terbinafine hydrochloride, a well-known medication for nail fungus, delivered with Dodecyl 2-(N, N dimethylamino)-propionate hydrochloride (DDAIP HCl), Apricus Bio's proprietary NexACT delivery technology, which enhances absorption of drugs through the skin and other barriers including the nail plate and nail bed. The Company believes MycoVa clinical trials have exhibited a significant mycological effect to eradicate the fungus and also has successfully demonstrated non-inferiority compared to Loceryl, the current topical standard of care for onychomycosis in Europe.
In addition, Apricus Bio believes the safety profile of topical terbinafine is significantly improved and much better tolerated than oral terbinafine, which is limited in use in some patients due to its potential for liver toxicity.
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