Med Check
FDA Advisory Panel Recommends Approval of Morphine Tablet
With Abuse-Deterrent Properties
A Food and Drug Administration (FDA) advisory panel in August voted 18-1 to recommend the approval of Arymo ER, an extended-release morphine tablet indicated for management of pain severe enough to require daily, around-the-clock treatment. Most members of the panel also voted favorably that if approved, Amyro ER be labeled as an abused-deterrent product by oral, nasal, and intravenous routes.
The recommendations were based on data presented from five phase 1 pharmacokinentic studies as well as two phase 3 human abuse liability studies. The abuse liability trials revealed that “drug liking” was significantly reduced when Arymo ER was manipulated compared with that of crushed MS Contin, an approved extended-release morphine formulation.
The FDA is not bound by the recommendations of its advisory panels, but will consider the guidance during the review of the new drug application for Arymo ER. The company said it expects to hear a decision from the FDA on this product by October 14.
Zydus, Sun Pharmaceuticals Issue Antidepressant Recall
Zydus Pharmaceuticals and Sun Pharmaceuticals Industries in July announced voluntary recalls of several lots of antidepressants in the U.S. market.
Zydus recalled 35 lots of its antidepressant venlafaxine HCl ER 75 mg and 150 mg capsules—a generic version of Effexor XR . The recall includes all 30-, 90-, and 1,000- count bottles with expiration dates from September 2017 to December 2017. (The company recommends that anyone with the affected lots discontinue the use, dispensing, and distribution of the product immediately.)
The recall was issued after tests revealed the medication has marginally higher dissolution rates than normal at different time points, which Zydus said poses a minimal risk to patients.
Failed dissolution specifications were said to also be behind Sun Pharmaceuticals Industries’ decision to recall of over 16,085 bottles of its antidepressant bupropion hydrochloride extended release 150 mg tablets (60-count bottles). Exposure to the recalled products is not expected to cause adverse health consequences.
Tau Aggregation Inhibitor Fails As Add-On Therapy, But Shows Promise as Monotherapy
TauRx Pharmaceuticals Ltd. in July announced that its tau protein aggregation inhibitor LMTX—intended to treat mild to moderate forms of Alzheimer’s disease—failed to meet primary endpoints in a phase 3 clinical trial involving 891 participants with mild to moderate Alzheimer’s disease (many took the medication in combination with their standard Alzheimer’s treatment regimen).
The company reported that patients who took LMTX as a monotherapy, however, experienced a statistically significant benefit on the cognitive and functional outcomes, and brain atrophy measured.
“These results support the targeting of the tau tangle pathology in Alzheimer’s disease as being a very promising drug development pathway,” Claude Wischik, Ph.D., co-founder of TauRx Pharmaceuticals, said in a press release. “However, the reason for the observed loss of efficacy of LMTX when taken in combination with currently available treatments for Alzheimer’s disease is not as yet understood.”
Participants were randomized to receive daily oral LMTM of 150 mg or 250 mg; to remain blinding, the control group received 8 mg of LMTX daily. Participants were stratified by disease severity, global region, and whether they were taking an Alzheimer’s medication.
Primary efficacy outcomes were change from baseline on standard measures of cognition and function, including the Alzheimer’s Disease Assessment Scale cognitive subscale and Alzheimer’s Disease Cooperative Study–Activities of Daily Living scale. These assessments were performed at baseline and every 13 weeks during the study. Study participants also received magnetic resonance imaging every three months.
FDA Advisory Panel Recommends Approval of Psoriasis Drug, But With Black-Box Warning
Valeant Pharmaceuticals announced in July that a FDA advisory panel recommended the approval of brodalumab for the treatment of moderate to severe plaque psoriasis despite several reports of suicidal ideation and behaviors by patients taking the medication.
Evidence presented to the panel shows 18 of the approximately 4,500 patients enrolled in clinical trials of the medication reported suicidal thoughts, eight patients attempted suicide, and six died by suicide.
While all of the 18 committee members voted in favor of the FDA’s approval of the medication, 14 also voted that additional risk-management options for suicidal ideation be implemented, FierceBiotech reports. ■
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Published online: 2 September 2016
Published in print: August 20, 2016 – September 2, 2016
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