Mayne Pharma launches BAC 300 capsules in the United States

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May 22, 2020, 01:44 ET

ADELAIDE, Australia, May 22, 2020 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the launch of butalbital acetaminophen and caffeine (BAC) capsule 50mg/300mg/40mg in the United States. Mayne Pharma received approval from the US Food and Drug Administration for its Abbreviated New Drug Application, which is indicated for the treatment of tension headache (migraine).

Mayne Pharma's CEO Scott Richards said, "This launch complements our existing butalbital product range that includes a variety of dosage forms, strengths and combinations. Mayne Pharma continues to expand its product portfolio through internal product development, strategic alliances with best-in-class pharmaceutical developers and manufacturers and other business development activities."

According to IQVIA, US sales of BAC capsule 50mg/300mg/40mg were approximately US$40 million for the 12 months ending 31 March 2020. Mayne Pharma directly markets more than 60 generic and specialty branded pharmaceuticals in the United States.

About Mayne Pharma

Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on applying its drug delivery expertise to commercialise branded and generic pharmaceuticals, offering patients better and more accessible medicines. Mayne Pharma also provides contract development and manufacturing services to more than 100 clients worldwide.

Mayne Pharma has a 40-year track record of innovation and success in developing new oral drug delivery systems and these technologies have been successfully commercialised in numerous products that continue to be marketed around the world.

Mayne Pharma has two facilities based in Salisbury, Australia and Greenville, USA with expertise in the formulation of complex oral and topical dose forms including potent compounds, modified-release products and poorly soluble compounds.

Indication and Usage

BAC capsules, 50mg/300mg/40mg are indicated for the relief of the symptom of complex tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because Butalbital is habit-forming and potentially abusable.

Selected Safety Information

Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product. This product is contraindicated under the following conditions: