Mayne Pharma launches Fabior, Sorilux
GREENVILLE, N.C. — Mayne Pharma on Wednesday announced the launch of Fabior (tazarotene, 0.1%) Foam and Sorilux (calcipotiene, 0.005%) Foam. Mayne Pharma acquired the products from GSK in August 2016, and they complement the company’s Doryx, the first branded product in its specialty brands division that it launched in 2015.
Fabior is a foam product indicated to ttreat acne, and it part of the single active retinoid market, which sees 5 million prescriptions written annually. The company said the market for Fabior is larger than then the oral antibiotic acne market Mayne Pharma’s Doryx participates in.
Sorilux is indicated for topical treatment of plaque psoriasis of the scalp and body, which affects as many as $6 million Americans annually and is part of the single active vitamin D market, which sees half a million prescriptions written every year.
“Both Fabior and Sorilux are a great strategic fit with the existing Doryx franchise and participate in attractive and growing markets. Both products are well differentiated with compelling clinical data that physicians and patients will appreciate,” Mayne Pharma CEO Scott Richards said. “The foam delivery platform has a well-established reputation with dermatologists due to ease of application, especially in hair-bearing areas and under clothing. With a focused and sustained marketing effort, we can further support the needs of patients and dermatologists and these products will become important treatment options for people with acne and plaque psoriasis.”
AstraZeneca announces Bevespi Aerosphere’s U.S. availability
WILMINGTON, Del. — AstraZeneca on Monday announced the availability of its Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol in the United States. The drug is indicated for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis or emphysema.
Bevespi Aerosphere was approved by the Food and Drug Administration in April 2016, and the company said it’s the first product approved using its co-suspension technology, which it says allows for consistent delivery of one or more medicines from the same pressurized metered dose inhaler.
“At AstraZeneca, we are committed to following the science to improve the lives of people living with respiratory diseases,” AstraZeneca VP U.S. respiratory Tosh Butt said. “I’m thrilled that Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol is now available in pharmacies across the US.”
FDA approves Egalet’s abuse-deterrent morphine Arymo ER
SILVER SPRING, Md. — The Food and Drug Administration has approved Arymo ER (morphine sulfate), an extended-release morphine tablet with abuse-deterrent properties, the company announced Monday.
The drug is indicated to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative options are inadequate. Egalet said Arymo ER is the first drug approved using its proprietary Guardian Technology, which works to deter abuse and prevent the tablets from being manipulated for abuse or misuse.
With the majority of ER opioids in easy to abuse forms, it is important that healthcare professionals have additional treatment options like Arymo ER that are resistant to different methods of manipulation using a variety of tools,” Egalet president and CEO Bob Radie, said. “Arymo ER has physical and chemical properties expected to make abuse by injection difficult, which is important given it is the most common non-oral route of morphine abuse and the most dangerous.”
Arymo ER was approved in 15-, 30- and 60-mg dosage strengths and the company expects a launch in the first quarter of 2017.
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