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Weekly Drug News Round-Up: May 16, 2018

FDA Approves Lucemyra: First Non-Opioid for Opioid Withdrawal Symptoms

Opioid withdrawal can occur both in patients who use prescribed opioids appropriately and in opioid use disorder Read More...

Today, the U.S. Food and Drug Administration (FDA) approved Lucemyra (lofexidine hydrochloride) from US WorldMeds to reduce the severity of withdrawal symptoms and allow a more abrupt discontinuation of opioids in adults. Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine thought to contribute to opiate withdrawal symptoms. It is not a treatment for opioid use disorder (OUD), but is used to help manage OUD. While Lucemyra may lessen the severity of withdrawal symptoms, such as anxiety, nausea, stomach cramps, and sleep problems, it may not completely prevent them and is only approved for treatment for up to 14 days.

Hospira’s Retacrit Approved as First Epoetin Alfa Biosimilar for Anemia

Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that details uses and risks Read More...

This week the FDA approved Hospira's Retacrit (epoetin alfa-epbx), a biosimilar to Epogen/Procrit (epoetin alfa), for treatment of anemia caused by chronic kidney disease, chemotherapy, use of zidovudine in patients with HIV, and reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Retacrit, an erythropoiesis-stimulating agent (ESA), was approved based on data showing that it is highly similar to Epogen/Procrit and has no clinically meaningful differences in terms of safety, purity and potency. As with other ESAs, a boxed warning informs of the risk of death, heart attack, stroke, blood clots and cancer progression or recurrence.

Truvada Now Cleared for PrEP in Adolescents to Reduce HIV Risk

In the U.S., those 13 to 24 years of age comprised 21% of all new HIV  infections in 2016, per the CDC Read More…

Once-daily oral Truvada (emtricitabine and tenofovir disoproxil fumarate) from Gilead now has an expanded use -- to reduce the risk of sexually acquired HIV-1 in at-risk, HIV-negative adolescents weighing at least 35 kg, along with safer sex practices. Truvada for HIV prevention in uninfected adults, a strategy called pre-exposure prophylaxis (PrEP), was approved in 2012 and is well established. The expanded use is based on the single-arm, open-label study ATN113 in which 67 HIV-1 negative, young men who have sex with men, age 15 to 17, all received Truvada once daily for PrEP. The most common side effects were similar to those seen in Truvada adult trials: headache, abdominal pain and weight loss.

Gilenya is First Drug Approved for Pediatric Multiple Sclerosis

Common pediatric side effects included headache, liver enzyme elevation, diarrhea, cough, flu, sinusitis, and back pain Read More...

Estimates suggest that 8,000 to 10,000 children and adolescents in the U.S. have multiple sclerosis (MS). In response, the FDA has approved Gilenya (fingolimod) from Novartis to treat relapsing MS in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients. In one clinical study, 214 pediatric patients ages 10 to 17 with MS participated. In the trial, Gilenya was compared to interferon beta-1a and 86% of patients receiving Gilenya remained relapse-free after 24 months of treatment, compared to 46% of those receiving interferon beta-1a.

Briviact Use Expanded to Treat Partial-Onset Seizures in Children

Clinicians can now prescribe Briviact to their pediatric patients as a tablet or oral solution Read More...

Pediatric epilepsy is thought to affect nearly 470,000 children in the U.S. The FDA has now expanded the use of Briviact (brivaracetam) oral products to include monotherapy and adjunctive therapy in the treatment of partial onset (focal) seizures in patients age four years and older. Briviact is a selective, high-affinity synaptic vesicle protein 2A ligand and analog of levetiracetam. Briviact approval is based on extrapolation of its efficacy data from adults to children, and is supported by safety and pharmacokinetics data collected in children. Common adult side effects include drowsiness, sedation, fatigue, nausea, and vomiting.