Apricus Biosciences Inc., a revenue-generating pharmaceutical company, has received the grant for Type C regulatory guidance from United States Food and Drug Administration (FDA) 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 (NDA) in the US.

The guidance will come from the Division of Dermatology and Dental Products within the Office of New Drugs in FDA's Centre for Drug Evaluation & Research (CDER). 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.

“This FDA guidance is an integral step in the process of bringing the safe and effective treatment benefits of MycoVa to patients suffering from mild to moderate onychomycosis,” said Bassam Damaj, PhD, president and chief executive officer of Apricus Bio. “Extensive clinical trial data and a robust international patent estate firmly support the marketing potential of MycoVa and we look forward to receiving necessary guidance from the FDA to move the process forward in the US.”

Apricus Bio was recently granted a Pre-New Drug Submission (Pre-NDS) meeting for MycoVa with Health Canada which is scheduled to take place on July 18, 2012, and the Company is also working with its European agents to conduct similar meetings with various European health agencies. The company is currently partnered with Stellar Pharmaceuticals Inc. for the commercialization and marketing of MycoVa in Canada following receipt of regulatory approval by Health Canada.

In a 2009 phase III clinical comparator study, MycoVa was determined to be no less effective than Loceryl in curing nail fungus. In this study, 1,029 patients with mild to moderate nail fungus were given either MycoVa (topical 10 per cent terbinafine hydrogen chloride formulation) or Loceryl (5% amorolfine nail laquer) for 48 weeks. The primary endpoint was a complete cure, and the secondary endpoints were killing the fungus and improving the appearance of the nail. A formal reanalysis of initial study results showed no significant difference in either primary or secondary endpoints between MycoVa and Loceryl. Loceryl is a registered trademark of Galderma.

MycoVa was also the subject of two phase III, randomized, double-blind, vehicle controlled, multicenter, parallel group studies to assess the efficacy, safety, and tolerability of MycoVa. A combined, post-hoc analysis of these two phase III clinical studies, completed by Apricus Bio in 2011, demonstrated statistically significant results in mycological cure, resulting in the eradication of nail fungus in favor of MycoVa treatment in patients that did not present with comorbid tinea pedis (athlete's foot).

In the company's view, MycoVa has distinct advantages over Loceryl for nail fungus suffers. MycoVa is simple and easy to apply, which could greatly improve patient compliance. The product is applied directly to the infected nails, typically at bedtime, accompanied by a simple washing with soap and water. The formulation allows significant amounts of the active ingredient to penetrate through the nail plate to the nail bed and surrounding area where fungus is located without significant systemic exposure. By contrast, Loceryl requires more patient care before applying the lacquer, including filing the affected areas of nail, including the nail surfaces, as thoroughly as possible. The surface of the nail should then be cleansed using disposable swabs. The nail lacquer is then applied onto the entire surface of the infected nail(s) using reusable applicators. Before repeat application of Loceryl, the affected nails should be filed down again and wiped with a cleansing pad to remove any residual lacquer.

Onychomycosis is a chronic persistent fungal infection of the nail bed resulting in thickening and discoloration of the nail, which sometimes can be accompanied by serious pain and disability. According to the Merck Manual, the worldwide incidence rate of onychomycosis is approximately 10 per cent.