Med Check

Appears Effective in Phase 2 Trial

Sage Therapeutics announced positive top-line results from its phase 2 clinical trial of SAGE-217 for the treatment of major depressive disorder (MDD). Compared with placebo, treatment with SAGE-217 resulted in a statistically significant greater reduction in the Hamilton Rating Scale for Depression (HAM-D) two weeks after treatment initiation. At day 15, 64 percent of patients who received SAGE-217 achieved remission (defined as a score of 7 or less on the HAM-D), compared with 23 percent of patients who received placebo.

SAGE-217 was generally well-tolerated with no serious or severe adverse events; the most common adverse events reported were headache, dizziness, nausea, and somnolence.

SAGE-217 is a potent and selective modulator of the GABAA receptor that is being tested as a once-daily, oral therapy for the treatment of various central nervous system disorders. This novel agent was given a fast-track designation by the Food and Drug Administration (FDA) in May 2017.

Sunovion Submits NDA For Novel ADHD Medication

The FDA has accepted Sunovion Pharmaceuticals’ New Drug Application (NDA) for dasotraline—a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adults. This drug has an extended half-life (47 to 77 hours) that supports the potential for achieving a continuous therapeutic effect with once-daily dosing.

According to Sunovion, the NDA includes data from multiple placebo-controlled safety and efficacy studies as well as two long-term studies that assessed the safety of dasotraline in people with ADHD for up to one year. These studies, which included about 2,500 people with ADHD, suggest the medication is generally well tolerated, the company said.

Dasotraline also is being tested as a treatment for binge eating disorder.

FDA Issues Health Advisory On Kratom

The FDA has issued a public health advisory on the use of kratom, a plant-based supplement that has been gaining popularity as a therapy for anxiety, depression, and pain.

Kratom, which is derived from trees native to southeast Asia, has many opioid-like properties. The use of kratom is also associated with serious side effects like seizures, liver damage, and withdrawal symptoms.

In a statement released in November 2017, FDA Commissioner Scott Gottlieb, M.D., noted that calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015. The use of kratom has also been linked to at least 36 deaths.

“The FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements,” Gottlieb said. “To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S.”

Tau Inhibitor Shows Promise In Second Phase 3 Trial

TauRx Therapeutics Ltd. reported positive results from its second phase 3 clinical study of LMTX, a novel Alzheimer’s drug designed to break up the tangles of tau protein that aggregate in the brains of Alzheimer’s patients.

A total of 800 patients with mild Alzheimer’s disease were randomly assigned to receive either 4 mg (the control dose) or 100 mg of LMTX twice daily over 18 months. About 20 percent of the participants took LMTX as a monotherapy, whereas the remainder took it in combination with other medications such as memantine.

The researchers found that patients taking 100 mg LMTX as monotherapy had significantly slower declines in both the Alzheimer’s Disease Assessment Scale–cognitive subscale (ADAS-Cog) and the Alzheimer’s Disease Co-operative Study–Activities of Daily Living (ADCS-ADL) compared with controls. These improvements were not seen in patients taking LMTX in combination with other medications, however, suggesting other medications may cause some interference.

MRI scans of the patients also revealed that after nine months, the brain atrophy rate among patients taking 100 mg LMTX monotherapy had slowed to levels similar to those seen in cognitively healthy elderly individuals. ■