FDA Approves Oravig(TM) (miconazole) Buccal Tablets for Treatment of Oropharyngeal Candidiasis
April 16, 2010
First and Only Local, Oral Prescription Formulation of Miconazole Approved for Thrush in the United States
WOODCLIFF LAKE, N.J., April 16, 2010 /PRNewswire via COMTEX/ --Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis (OPC), more commonly known as thrush, in adults and children age 16 and older. Oravig is the first and only local, oral prescription formulation of miconazole - an antifungal medication - approved for this use in the U.S.
Oravig, which adheres to the gum, utilizes innovative buccal tablet technology enabling once-daily dosing that delivers miconazole directly at the local site of infection throughout the day with minimal systemic absorption. Oravig is easy-to-use and provides patients with a flavorless, odorless and convenient treatment option that does not interfere with daily activities such as eating and drinking.
Oravig will be offered in a 50 mg dosage strength and is expected to be available in retail pharmacies in the third quarter of 2010.
"The FDA approval of Oravig underscores Strativa's commitment to improving patients' overall treatment experience by bringing to market new products that fulfill patient needs," said John A. MacPhee, President, Strativa Pharmaceuticals. "Oravig offers patients suffering from thrush a proven effective treatment in a discreet and convenient once-daily formulation."
The FDA approval was based on two pivotal Phase III clinical trials. The first study demonstrated that Oravig completely resolved signs and symptoms of OPC at rates similar to Mycelex(R) Troche (clotrimazole) administered five times per day in HIV-positive patients. This randomized, double-blind, double-dummy trial was conducted in 577 HIV-positive patients in 28 sites in the United States, Canada, and South Africa. A second randomized, open-label, multicenter comparative trial conducted in 282 patients who underwent radiotherapy for head and neck cancer showed that Oravig is safe and effective in this patient population who often has reduced salivary flow.
OPC is an oral fungal infection most common in individuals with weakened immune systems - particularly those with HIV/AIDS and those undergoing certain cancer treatments. OPC is a disruptive condition that results in lesions and inflammation in the mouth, and includes symptoms such as soreness, pain, burning and/or altered taste.
Oravig is approved in 26 countriesand is currently being marketed in several EU territories including France, Germany and the UK under the trade name Loramyc(R).
Under an exclusive licensing agreement with BioAlliance Pharma, Strativa received the exclusive U.S. commercialization rights to Oravig (miconazole) buccal tablets. Under the terms of the agreement, the FDA approval triggered a $20 million milestone payment from Strativa to BioAlliance, for total milestone payments to date in the amount of $35 million. In addition to royalties on sales, BioAlliance may receive milestone payments on future sales.
Indication and Important Safety Information for Oravig
Oravig (miconazole) is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults.
Oravig (miconazole) is a buccal tablet designed to adhere to the gum. Patients should be advised not to crush, chew, or swallow the tablet.
During clinical trials, the most common adverse events (greater than or equal to 2%) reported with Oravig were diarrhea (6.0%), nausea (4.6%), headache (5.0%), dysgeusia (2.9%), upper abdominal pain (2.5%), and vomiting (2.5%).
Oravig is contraindicated in patients with a known hypersensitivity to miconazole, milk protein concentrate, or any other component of the product. Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the administration of miconazole. Discontinue Oravig immediately at the first sign of hypersensitivity. There is no information regarding cross-hypersensitivity between miconazole and other azole agents. Monitor patients with a history of hypersensitivity to azoles.
About Strativa Pharmaceuticals
Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), excels at finding, enhancing, and bringing to market drugs that make a meaningful difference to patients. For more information about Strativa, visit www.strativapharma.com.
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc, is a U.S.-based specialty pharmaceutical company. Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets higher-barrier-to entry generic drugs and niche, innovative proprietary pharmaceuticals. For press release and other company information, visit www.parpharm.com.
About BioAlliance Pharma
BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The company develops and commercializes innovative products that address resistance issues. For press release and other company information, visit www.bioalliancepharma.com.
Safe Harbor Statement
Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2009, in other of the Company's filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.