Med Check

Latuda Receives New Indication for Pediatric Bipolar Depression

The Food and Drug Administration (FDA) in March approved Sunovion Pharmaceuticals’ Latuda (lurasidone HCl) for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in youth aged 10 to 17.

According to Sunovion, the approval for this expanded pediatric indication was based on data from a six-week, phase 3 clinical trial of 347 children and adolescents with bipolar depression. After six weeks, the participants who received once-daily Latuda (20 to 80 mg/day) showed statistically significant improvements in depression symptoms compared with those taking placebo on multiple rating scales.

The medication was generally well tolerated, with nausea, weight gain, and insomnia being the most common adverse effects.

Latuda is already approved as a monotherapy or adjunctive therapy with lithium or valproate for the treatment of adults with bipolar depression. The medication is also approved for the treatment of adults and adolescents (aged 13 to 17) with schizophrenia.

Biogen Purchases Schizophrenia Drug in Development at Pfizer

Biogen in March announced it has purchased from Pfizer a drug in development to treat cognitive impairment associated with schizophrenia.

Biogen has agreed to pay $75 million up front for the drug, an AMPA receptor modulator known as PF-04958242. Pfizer will receive additional capital and royalties should this drug receive FDA approval and go to market.

Pfizer had completed phase 1 safety studies with PF-04958242 prior to the sale. Once the deal is finalized, Biogen said it plans to move the medication into phase 2 safety and efficacy studies.

Vertex Pharma’s Nonopioid Painkiller Shows Promise in Second Phase 2 Study

Vertex Pharma in February reported positive data from a phase 2 study of its analgesic drug VX-150, a sodium channel blocker that may offer a nonaddictive alternative to opioid painkillers.

The study involved 243 patients who were randomly assigned to VX-150, hydrocodone plus acetaminophen, or placebo for two days following bunionectomy surgery. VX-150 outperformed placebo in alleviating pain at both 24 and 48 hours. The drug also seemed to perform as well as hydrocodone plus acetaminophen, although the study was not statistically powered to make a direct comparison between the two active arms. VX-150 was generally well tolerated. There were no serious adverse events in any arm of the study, and no discontinuations due to adverse events.

VX-150 had previously produced positive pain relief results in a phase 2 trial involving patients with chronic osteoarthritis pain. A third phase 2 study of VX-150 for treating neuropathic pain is currently under way.

Positive Phase 3 Results Reported for Investigational Sleep Medication

Eisai and Purdue Pharma announced positive topline results in February from a pair of studies involving lemborexant, its investigational agent being tested as a treatment for multiple sleep disorders.

The first study was a large phase 3 trial known as SUNRISE 1, which compared the efficacy and safety of lemborexant (5 mg or 10 mg) with extended-release zolpidem (6.25 mg) and placebo in about 1,000 patients aged 55 and older with insomnia disorder.

In a press release, the companies noted that lemborexant met its primary endpoint; people fell asleep faster than they did on placebo.

In a separate phase 1 study, researchers compared how healthy adults taking lemborexant (5 mg or 10 mg) and zolpidem (6.25 mg) responded if awakened four hours after taking the medication. Those who took zolpidem were found to have clinically worse balance and stability compared with adults who took either dose of lemborexant.

FDA Approves Osmotica’s Extended-Release Amantadine for Parkinson’s

In February, the FDA approved Osmotica Pharmaceutical’s extended-release amantadine formulation (Osmolex ER) for the treatment of both Parkinson’s disease and drug-induced extrapyramidal symptoms in adults.

Osmolex ER will be available in three once-daily dosage options: 129 mg, 193 mg, and 258 mg tablets, with a maximum daily dose of 322 mg. ■