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FDA OKs first orally disintegrating tablet for ADHD

The FDA has approved the amphetamine extended-release, orally disintegrating tablet (Adzenys XR-ODT) for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients age 6 and older. According to the manufacturer, Neos Therapeutics, the medication is the first and only extended-release ODT for ADHD treatment in both children age 6 and older and adults.


The FDA approved Adzenys XR-ODT based on data showing the drug is the bioequivalent of a previously approved, mixed amphetamine salts extended-release capsule (Adderall XR). Adzenys XR-ODT will be available in six dosage strengths.


New drug approved for chronic HCV

The FDA approved Merck's elbasvir and grazoprevir (Zepatier) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 or 4 infections in adults.


It is recommended that healthcare professionals screen genotype 1a infected patients for certain viral genetic variations prior to starting Zepatier treatment to determine dosage regimen and duration.


There is a risk of alanine aminotransferase level elevations with Zepatier use, and liver-related lab tests should be performed prior to starting therapy and at certain times during treatment. Zepatier is contraindicated in patients with moderate or severe liver impairment.


First breath-powered intranasal migraine treatment approved

The FDA approved Avanir Pharmaceutical's sumatriptan nasal powder Onzetra Xsail for acute treatment of migraine with or without aura for adults. Onzetra Xsail, a serotonin 5-HT1B/1D receptor agonist, is an intranasal medication delivery system consisting of a fast-acting dry powder formulation of sumatriptan delivered in a two-step process using the novel Xsail Breath Powered Delivery Device.

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The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. The exhaled breath carries medication from the device directly into one side of the nose through a sealing nosepiece placed into the nostril. Narrow nasal passages are expanded, and medication is dispersed deep into the nasal cavity where it can be rapidly absorbed. The air flows around to the opposite side of the nasal cavity and exits through the other nostril as the medication is delivered. Closure of the soft palate helps prevent swallowing and reduces gastrointestinal absorption.


The most common adverse reactions in clinical trials included abnormal taste, nasal discomfort, rhinorrhea, and rhinitis. Onzetra Xsail has numerous contraindications, including cardiovascular disease, ischemic bowel disease, and severe hepatic impairment. Consult the product labeling for more details on contraindications and serious adverse reactions associated with sumatriptan use.


Rapastinel receives FDA breakthrough therapy designation

Allergan's investigational medication rapastinel has been granted a designation as breakthrough therapy for adjunctive treatment of major depressive disorder (MDD). The decision follows the FDA's granting of fast-track designation for rapastinel in 2014.

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Rapastinel is an investigational I.V. formulation of a novel N-methyl-d-aspartate receptor partial agonist that has shown a rapid onset of antidepressant efficacy 1 day after a single dose in a phase 2 trial of patients with MDD who had an inadequate response to one or more antidepressants.


The agency's decision was based on preclinical and preliminary clinical evidence for rapastinel that supports a rapid and sustained antidepressant effect over the course of the Phase II studies. Rapastinel has been found to be well tolerated in studies to date, with no psychotomimetic or hallucinogenic adverse reactions observed.