FDA Approved Drugs: February 2020

FDA Approved Drugs: February 2020

FDA Approved Drugs: February 2020

Pizensy (lactitol): Braintree Labs

Pizensy (lactitol) is an osmotic laxative therapy indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Pizensy will be supplied as a powder for oral solution as 280 grams and 560 grams of lactitol in multi-dose bottles, as well as 28 unit-dose packets each containing 10 grams of lactitol. The product can be mixed with the patient’s fluid of choice and is taken once daily, preferably with meals. Pizensy is expected to be available in the United States in H2 2020. Pizensy is a New Chemical Entity and is expected to have patent protection until 2037.

Nexletol & Nexlizet (bempedoic acid and ezetimibe): Esperion Therapeutics

Nexletol is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver. Nexletol will be commercially available in the United States by March 30, 2020.

Nexlizet is a combination of an adenosine triphosphate-citrate lyase (ACL) inhibitor, bempedoic acid, and ezetimibe, a cholesterol absorption inhibitor.

The FDA approval of Nexletol and Nexlizet provides an important option for patients living with elevated LDL-C and ASCVD or increased risk for cardiovascular disease. High LDL, or bad cholesterol, is one of the top risks for heart attacks and other problems.

Barhemsys (amisulpride):Acacia Pharma

Barhemsys is the first and only antiemetic approved therapy for the ‘rescue treatment’ (patients who are uncontrolled following prophylactic treatment with standard-of care-antiemetics) and prophylaxis of Postoperative Nausea and Vomiting (PONV) in patients who have failed prior prophylaxis using current standard of care. It is an intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride (2.5 mg/mL).

Nurtec ODT (rimegepant):Biohaven Pharmaceuticals

Nurtec ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT).The approval of Nurtec ODT was based on efficacy data from a randomized, double-blind, placebo-controlled Phase III trial that compared Nurtec ODT with placebo in 1466 adult patients for the acute treatment of migraine with and without aura. Nurtec ODT will be supplied as 75mg orally disintegrating tablets in a blister pack of 8 and is expected to be available in early March 2020.

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