SAN DIEGO, May 22, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that the United States ("U.S.") Food and Drug Administration ("FDA") 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 ("NDA") 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 ("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 U.S."
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.
About MycoVa™
In a 2009 Phase 3 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% 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 3, 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 3 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.
About Onychomycosis
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%. As described by Iorizzo and Piraccini (2007), the incidence has been increasing due to diabetes, immunosuppression and an aging population. While occurring in approximately 2.6% of children younger than 18 years, it occurs in as much as 90% of the elderly population (eMedicine.medscape.com). As of 2008, Thomson Reuters Pharma had stated that the worldwide market was approximately $2.8 billion in size and is expected to grow to approximately $2.9 billion by 2014.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based revenue-generating pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.
Revenues and growth are driven from the sales of the Company's commercial products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc. subsidiaries and through out-licensing in certain territories of its product pipeline and NexACT® technology.
Apricus Bio's current NexACT® pipeline includes Vitaros®, approved in Canada for the treatment of erectile dysfunction, as well as compounds in development from pre-clinical through pre-registration currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Consumer Healthcare.
Apricus Bio currently markets Totect® (dexrazoxane HCl), the only drug approved in the US for the treatment of anthracycline extravasation. The Company also plans to market in the U.S. or certain other countries the following products: (a) Granisol® (granisetron HCI) oral solution, the only FDA-approved, oral, ready-to-use liquid solution of granisetron, (b) Aquoral™, an FDA-cleared, prescription-only spray for the treatment of Xerostomia (the medical term for dry mouth due to a lack of saliva) and (c) NitroMist™ (nitroglycerin sublingual spray), an FDA-approved nitrate vasodilator indicated for acute relief of an attack or acute prophylaxis of angina pectoris (chest pain) due to coronary artery disease (narrowing of the blood vessels that supply blood to the heart).
The Company also expects to develop and/or acquire and then bring to market additional pharmaceutical products in areas of care that will benefit patient needs worldwide.
For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiary please visit http://www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to further develop its products and product candidates, to have its products and product candidates such as MycoVa™ receive patent protection and be approved by relevant regulatory authorities, to successfully commercialize such products as Totect® , Granisol® , Aquoral™ and NitroMist™ and Vitaros® for erectile dysfunction and NexACT® product candidates and drug delivery technology and to achieve its development, commercialization and financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.