New Products for Pharmacists 08-10-2016
RX CARE: New drugs
FDA approved dronabinol oral solution (Syndros, INSYS Therapeutics), an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol. Dronabinol is indicated for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
“Syndros is the first and only FDA approved dronabinol solution for oral use. It is a liquid that is easy-to-swallow and allows for the dosage to be titrated to clinical effect. Once Syndros has been opened, it does not need to be refrigerated for 28 days,” John N. Kapoor, the company’s chairman, CEO, and president. “We believe that these product features coupled with patient support services will prove to be important differentiators for patients and prescribers and will be key drivers of a successful market launch and sustained growth,” Kapoor said. (www.insysrx.com)
FDA has approved Xiidra (lifitegrast ophthalmic solution) for the treatment of dry eye disease. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) agonist, approved for dry eye disease. “Normal tear production is needed for clear vision and eye health,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “This approval will provide a new treatment option for patients with dry eye disease.” (www.shire.com)
Amgen has announced that FDA has approved its Repatha (evolocumab) Pushtronex system, a new, monthly single-dose administration option. Pushtronex system is a hands-free device designed to provide 420 mg of Repatha in a single dose. “The Pushtronex system exemplifies Amgen’s continued innovation and commitment to patients,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration. The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL cholesterol lowering that Repatha can provide.” (www.amgen.com)
Protein Sciences has announced that FDA has extended the shelf life for Flublok, its seasonal influenza vaccine, to nine months from the date of manufacture. “We are pleased to add an extended shelf life to the list of product improvements we have been able to achieve for Flublok,” said Penny Post, Protein Sciences’ VP regulatory affairs. “We were first able to expand the approved age range for Flublok to everyone 18 years and older in October 2014. In addition to the nine-month shelf life we just achieved, Flublok Quadrivalent is under review and FDA approval is anticipated this fall. We are working towards securing a one-year shelf life as well.” (www.flublok.com)
FDA has approved Allergan’s Byvalson (nebivolol 5 mg and valsartan 80 mg) tablets. The drug is indicated to treat hypertension, and according to the product maker it is the first fixed-dose combination of a beta-blocker and an angiotensin II receptor blocker in the United States.
“Achieving blood pressure control is critical to reducing the risk of serious and life-threatening cardiovascular events,” said David Nicholson, Allergan’s chief R&D officer. “There remains a need for new therapies, as observed by the nearly half of patients in the United States who remain uncontrolled. We are pleased with the FDA approval of Byvalson, which will provide physicians a new fixed-dose combination therapy treatment option for patients affected by hypertension.” (www.cia1.allergan.com)