Med Check
GABAA Receptor Modulator Found To Rapidly Reduce Symptoms Of Postpartum Depression
Sage Therapeutics’ SAGE-547, a GABAA modulator delivered intravenously, may one day offer a new treatment option for women experiencing severe postpartum depression, according to the results of a phase 2 trial released in July.
The trial included 21 women with severe postpartum depression (Hamilton Rating Scale for Depression [HAM-D] scores equal to or greater than 26) who were less than six months postpartum at the start of the trial. These women were randomly assigned to receive SAGE-547 or placebo intravenously for 60 hours.
The results showed that women who received SAGE-547 experienced a 19.0 point mean reduction in HAM-D scores at 24 hours, achieving a greater than 10.6 point difference from placebo at that time point. This was maintained at similar magnitude out to 30-day follow-up.
Remission from depression (defined by HAM-D scores less than or equal to 7) measured at 60 hours, was seen in 7 of 10 patients who were administered SAGE-547 and 1 of 11 placebo patients. Similarly, at 30 days, 7 of 10 of the SAGE-547 group and 2 of 11 in the placebo group were in remission.
Overall SAGE-547 was well tolerated with reported adverse events including dizziness, sedation, and somnolence.
The company has initiated an expansion of this phase 2 clinical program to determine optimal dosing of SAGE-547 in postpartum depression.
Shire’s SHP465 Shows Promise In Adults With ADHD
Shire Plc. in June announced positive results from a randomized, double-blind trial of its investigational oral medication SHP465 (triple-bead mixed amphetamine salts) in adults with attention-deficit/hyperactivity disorder (ADHD).
A total of 275 adults aged 18 to 55 with ADHD were randomly assigned to receive SHP465 (12.5 mg or 37.5 mg) or placebo daily for four weeks. The researchers found that from baseline to week 4, mean ADHD Rating Scale total scores decreased by 8.1 points among the 12.5 mg group and 13.3 points among the 37.5 mg group. Clinical Global Impression Improvement Scale total scores measuring ADHD severity also significantly decreased over the study period.
The most common treatment-emergent adverse events included decreased appetite, dry mouth, insomnia, and headache. Adverse events were generally mild to moderate in severity and similar to those observed in other amphetamine compounds.
Shire is planning to submit the data to the Food and Drug Administration (FDA) by the end of 2016, with hopes of obtaining FDA approval for SHP465 by the end of 2017.
CMS Reports Antipsychotic Use on Decline in Nursing Homes
The number of antipsychotic drugs prescribed off-label to nursing home residents since 2011 appears to have fallen, according to a report by the Centers for Medicare and Medicaid Services (CMS) released in June.
In 2011, the Office of the Inspector General of the Department of Health and Human Services released a report that found 83 percent of claims for antipsychotics were for nursing home residents who had not been diagnosed with a condition for which antipsychotic medications were approved by the Food and Drug Administration.
In its report, the CMS noted that national prevalence of off-label antipsychotic use for long-stay nursing home residents without schizophrenia, Huntington’s disease, or Tourette’s Syndrome dropped from 23.9 percent in the fourth quarter of 2011 to 17.4 percent in third quarter of 2015—a 27 percent decrease.
CMS established a national goal of reducing the use of antipsychotic medications in long-stay nursing home residents by 30 percent by the end of 2016.
Johnson & Johnson to Pay $70M for Failure to Warn About Risperdal Side Effects
In the fifth case to go to court in Pennsylvania concerning Risperdal (risperidone), Johnson & Johnson and its subsidiary Janssen Pharmaceuticals were found liable for failing to warn that the antipsychotic has the potential to cause gynecomastia (breast formation) in boys and young men. As a result, the pharmaceutical giant was ordered to pay $70 million to the plaintiff, the largest amount in Risperdal litigation thus far.
Parents of the 16-year-old plaintiff filed suit against the pharmaceutical giant after claiming that the drug caused their son to develop breasts. The lawsuit stated that the parents never knew the drug could cause gynecomastia and that Johnson & Johnson intentionally hid studies showing such risks.
According to Philly.com, Janssen officials said in a statement that the company would appeal and disputed that the drug had caused the plaintiff to develop breasts.
Johnson & Johnson has approximately 1,500 lawsuits pending in Pennsylvania for Risperdal-associated gynecomastia in young males. ■
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Published online: 18 August 2016
Published in print: August 6, 2016 – August 19, 2016
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