Med Check
FDA Panel Not Persuaded By Data for Gepirone
A Food and Drug Administration (FDA) advisory panel last month voted against FDA approval of gepirone hydrochloride extended-release (HCL-ER) for treating patients with major depressive disorder (MDD). While the Psychopharmacologic Drugs Advisory Committee (PDAC) did agree that the medication is safe, the majority of the committee members felt that “substantial evidence of effectiveness” in treating MDD was lacking.
The agency previously rejected a New Drug Application for gepirone HCL-ER in 2002, 2004, and 2007 due to a lack of positive results and concerns raised in failed trials.
In 2010, Fabre-Kramer—the company that owns rights to the medication—appealed the 2007 decision to the director of the FDA’s Office of New Drugs, which granted last month’s PDAC review of gepirone HCL-ER. However, prior concerns expressed by the FDA that led to the drug’s being rejected multiple times were also expressed by PDAC.
Though gepirone HCL-ER was not recommended for FDA approval, a representative from Fabre-Kramer told Psychiatric News in an email that the company remains “cautiously optimistic” about the agency’s decision on the medication.
Gepirione HCL-ER, which acts as a selective partial agonist of the 5-HT1A receptor, is classified as both an antidepressant and antianxiolytic of the azapirone class.
FDA Drug Shortages, Discontinuation List Include Six Psychotropic Drugs
Pharmaceutical manufacturers have reported that the following psychotropic medicines have been discontinued or are in short supply as Psychiatric News went to press.
Discontinued:
•
Abilify (aripiprazole) Oral solution 1mg/mL - Discmelt orally disintegrating tablets 10 mg and 15 mg - Injection for intramuscular use only 9.75 mg/1.3 mL (7.5 mg/mL)
•
Ativan (lorazepam injection) - 2 mg/mL; 1 mL iSecure syringe
In short supply:
•
Haloperidol lactate injection
•
Methylin chewable tablets
•
Methylphenidate hydrochloride ER capsules/tablets
•
Surmontil (trimipramine maleate capsules)
Drug discontinuations and shortages can be accessed here.
Generic Psychotropic Drugs Linked to Big Cost Savings for Health Care
A report sponsored by the Generic Pharmaceutical Association (GPhA) shows that the U.S. health care system saved billions of dollars in 2014 through use of generic drugs, with mental health care reaping the biggest cost savings.
“This new report reinforces that generic drugs are a critical part of any solution to rising costs for patients, payers, and the entire health care system,” said Chip Davis, J.D., president and CEO of GPhA, in a press statement. “Safe, effective, and more affordable generic medicines mean increased access for the millions who rely on these life-saving therapies.”
In 2014, the U.S. health care system saved $254 billion by using generics, bringing the total savings from 2004 to 2014 to $1.68 trillion, according to the report. Generics for mental illness (which included savings for antidepressants and antipsychotics only) saved the health care system $38 billion, followed by generics to treat hypertension and cholesterolemia, which, respectively, saved $27.9 billion and $26.8 billion.
Although the report showed that generics accounted for approximately 88 percent of prescriptions dispensed in the United States in 2014, generics accounted for only 28 percent of total drug spending.
The report can be accessed here.
Novel Adjunctive Medication for Schizophrenia Reaches Phase 2
In December, Newron Pharmaceuticals announced the initiation of a phase 2 study with the novel sodium channel blocker NW-3509 , intended to be used as an adjunctive therapy in patients with schizophrenia. The compound specifically targets voltage-gated sodium channels, normalizing glutamate release induced by aberrant sodium channel activity.
According to the company, the four-week double-blind, placebo-controlled, randomized trial will be performed at two U.S. study centers with a minimum of 60 participants who are experiencing breakthrough psychotic symptoms while taking atypical antipsychotics. Participants will be administered 5 mg to 25 mg of NW-3509 or placebo twice a day.
The potential benefits of NW-3509 have been demonstrated in numerous preclinical models predictive of efficacy in psychiatric diseases, including models of psychosis, mania, and depression. Results of the trial are expected to become available at the end of 2016. ■
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Published in print: December 19, 2015 – January 1, 2016
Published online: 5 January 2016
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