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Weekly Drug News Round-Up: June 21, 2017

FDA Approves Shire’s Once Daily Mydayis for ADHD

Shire expects to make Mydayis commercially available in the third quarter of 2017 Read More...

This week the U.S. Food and Drug Administration (FDA) cleared Shire’s Mydayis (amphetamine mixed salts), a long-acting central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. In Phase 3 studies, a morning dose of Mydayis improved symptoms of ADHD as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents. The effect reached statistical significance beginning at 2 or 4 hours post-dose and lasted up to 16 hours. Common side effects included insomnia, decreased appetite, decreased weight, irritability and anxiety, among others.

Orally Disintegrating Cotempla XR-ODT Now Approved for ADHD

Cotempla XR-ODT, from Neos Therapeutics, will be available in the fall of 2017 Read More...

The FDA has approved Cotempla XR-ODT (methylphenidate), a once-daily, extended-release, orally disintegrating tablet (ODT) formulation of the central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. In Phase 3 studies, Cotempla XR-ODT showed a significant improvement in ADHD symptom control compared to placebo across the day in a laboratory classroom setting. Onset of effect was evident at one hour post-dose and lasted through 12 hours. In addition, the adverse event profile was consistent with the established safety profile for other extended-release methylphenidate products.

New Fluoroquinolone Baxdela Approved for Certain Skin Infections

Baxdela is available in both intravenous (IV) and oral formulations Read More...

Roughly 3 million patients are hospitalized each year in the U.S. with acute bacterial skin and skin structure infections (ABSSSI), some of which may be difficult-to-treat and show antibiotic resistance. In response, the FDA has approved Baxdela (delafloxacin) from Melinta Therapeutics, a fluoroquinolone antibiotic for ABSSSI caused by susceptible bacteria. Baxdela targets both gram-positive and gram-negative bacteria, including the serious pathogen MRSA (methicillin-resistant Staphylococcus aureus). In Phase 3 non-inferiority studies, IV and oral Baxdela were shown as effective as vancomycin plus aztreonam at 48-72 hours. Fluoroquinolones as a class have been linked to serious, possibly permanent side effects that may involve the tendons, muscles, joints, nerves, and central nervous system.

Symjepi: A New Epinephrine Product Approved in a Pre-Filled Syringe

The junior version of Symjepi will also be submitted to the FDA for approval Read More...

The FDA has approved a new, single-dose, pre-filled syringe of epinephrine known as Symjepi. Symjepi, from Adamis, is used for the emergency treatment of allergic reactions (Type I) including anaphylaxis. The product provides two single dose syringes of epinephrine which is considered the drug of choice in acute anaphylactic reactions such as insect stings, food allergies (such as nuts or shellfish), or medications, among others. The manufacturer reports that Symjepi will have a lower cost, smaller size and more user-friendly design, and is expected to launch later this year. Other brands in the epinephrine autoinjector space include EpiPen, Adrenaclick, and Auvi-Q. Generics are now also available.

Anti-Nausea Drug More Effective for Migraines Than Opioid: Study

The study was stopped early because the relief difference was so large Read More...

Prochlorperazine, a medication for severe nausea and vomiting, has been found more effective than the opioid hydromorphone in treating emergency room patients with acute migraine. In the study, patients received either prochlorperazine plus diphenhydramine (Benadryl) or hydromorphone (Dilaudid), and were assessed for sustained headache relief: mild or no headache at 2 hours and sustained for 48 hours after one dose. Sixty percent of patients who received prochlorperazine had sustained relief, compared to 31 percent in the hydromorphone group. Experts suggest to offer acute migraine patients IV prochlorperazine, metoclopramide, or subcutaneous sumatriptan, but not morphine or hydromorphone, due to lack of efficacy, side effects, and potential for abuse.