Apricus Biosciences Inc. (APRI) announced that Health Canada has granted the Company's request for a Pre-New Drug Submission or Pre-NDS meeting to obtain regulatory guidance from the agency for MycoVa, the company's topical treatment for onychomycosis, or nail fungus.
The meeting is scheduled to take place July 18, 2012. Apricus Bio expects to obtain feedback from Health Canada regarding the suitability of its Phase 3 development program to support a New Drug Submission or "NDS" in Canada.
In addition, the company is seeking guidance from the US Food and Drug Administration and will be filing for guidance from the European Health Agency.
MycoVa is a topically applied formulation of terbinafine hydrochloride, a well-known medication for nail fungus, delivered with Dodecyl dodecyl 2-(N, N dimethylamino)-propionate hydrochloride, 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.
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