Rx Product News (March 20)

ICOSAPENT ETHYL (VASCEPTA)MANUFACTURED BY: Amarin Pharma, Inc

The FDA recently approved icosapent ethyl in adults with cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of cardiovascular issues requiring hospitalization. When combined with a healthy diet, the 4-gram daily dose of icosapent ethyl is clinical proven to lower very high triglycerides in adults by 33% without raising low-density lipoprotein. In studies, patients taking the drug had similar adverse effects compared with patients receiving a placebo, including joint pain. Serious adverse effects may include allergic reactions, bleeding, or heart-rhythm problems.

FOR MORE INFORMATION: vascepta.com

TAZAROTENE LOTION (ARAZLO)MANUFACTURED BY: Bausch Health Companies Inc

The FDA has approved tazarotene lotion, 0.045%, for the topical treatment of acne vulgaris in patients aged 9 years and older. It is the first tazarotene acne treatment available in lotion form, and it has shown strong efficacy as well as favorable tolerability. The formulation was developed to minimize the dryness and irritation typically associated with tazarotene, which can frequently cause patients with acne to discontinue treatment. The launch of the lotion is timed to coincide with the start of acne season in the first half of 2020.

FOR MORE INFORMATION: bauschhealth.com

LEMBOREXANT (DAYVIGO)MANUFACTURED BY: Eisai Inc

The fDA recently approved lemborexant in 5-mg and 10-mg doses for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Not only does insomnia have short-term effects on patients' ability to function, it also has long-term consequences for health and well-being. The approval was based 2 pivotal phase 3 studies, which evaluated lemborexant versus a placebo for up to 1 month and up to 6 months. The most common adverse reaction was somnolence, while the most common adverse reactions leading to discontinuation were nightmares and somnolence.

FOR MORE INFORMATION: eisai.com

LUMATEPERONE (CAPLYTA)MANUFACTURED BY: Intra-Cellular Therapies, Inc

Caplyta capsules in a 42-mg dose have been approved for adult patients with schizophrenia. The drug is an atypical antipsychotic and should be taken with food. Serious precautions and warnings include agranulocytosis, leukopenia, and neutropenia; cerebrovascular adverse reactions in elderly patients with dementia-related psychosis; metabolic changes; neuroleptic malignant syndrome, neutropenia; orthostatic hypotension and syncope; the potential for cognitive and motor impairment; seizures; and tardive dyskinesia. In clinical trials, the most common adverse reactions with lumateperone versus placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs 2%).

FOR MORE INFORMATION: caplyta.com