Med Check
FDA Warns Retailers About E-Cigarette Violations
The Food and Drug Administration (FDA) recently announced it had issued warning letters to 55 tobacco retailers for selling e-cigarettes, e-liquids, cigars, and more to minors. In August, the agency began to enforce new federal regulations making it illegal nationwide to sell these and other products to anyone under 18. (Psychiatric News, June 3)
As part of the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA conducts inspections and monitors retailer compliance of federal tobacco laws and regulations. If violations are uncovered, the agency typically issues warning letters before pursuing enforcement actions, which may include civil money penalties and no tobacco sale orders.
Data from the FDA and the Centers for Disease Control and Prevention showed current e-cigarette use among high school students between 2011 and 2015 increased by more than 900 percent, and hookah use also increased significantly during this time.
ITI-007 Falls Short in Phase 3 Trial
Intra-Cellular Therapies Inc. announced in late-September that the antipsychotic ITI-007 failed to outperform placebo in the second phase 3 trial of the ITI-007 drug development program.
The announcement comes approximately one year after the company published positive results from its first phase 3 trial of the investigational therapy (Psychiatric News, September 18, 2015.
The current study was a multisite clinical trial that included 696 patients with schizophrenia who were randomized to receive either 20 mg or 60 mg of ITI-007, 4 mg of risperidone (active control group), or placebo once daily for six weeks. The primary measure was change from baseline to six weeks on Positive and Negative Syndrome Scale compared with placebo.
ITI-007 60 mg and 20 mg demonstrated a change from baseline on the PANSS total score of -14.6 points and -15.0 points, respectively, versus a -15.1 point change in placebo. Risperidone demonstrated a change from baseline on the PANSS total score of -20.5 points.
ITI-007 was found to be statistically significantly better than risperidone on key safety and tolerability parameters—such as extrapyramidal symptoms, body weight, glucose levels—and exhibited a safety profile similar to placebo.
“We believe ITI-007 did not separate from placebo on the pre-specified study endpoint … in part due to an unusually high placebo response at certain sites which disproportionately affected the trial results and contributed to the efficacy outcome of this study compared to our two previous efficacy studies,” the company stated in a press release.
Phase 2b Trial of ADHD Medication Yield Promising Results
Supernus Pharmaceuticals Inc. has announced that a phase 2b clinical trial of its attention-deficit/hyperactivity disorder medication SPN-812—a selective norepinephrine reuptake inhibitor—has revealed the medication to be effective at reducing symptoms of ADHD at multiple doses.
The double-blinded, multicenter trial included 222 children aged 6 to 12 who were randomized to receive SPN-812 at 100 mg, 200 mg, 300 mg, or 400 mg doses or placebo once daily over five weeks, after a three-week titration phase.
Patients receiving SPN-812 400 mg, 300 mg, and 200 mg had significant reductions in scores on the ADHD Rating Scale-IV from study baseline to endpoint, dropping 19.0 points, 18.6 points, and 18.4 points, respectively. Patients receiving 100 mg of SPN-812 or placebo had, respectively, a reduction of 16.7 points and 10.5 points.
The most frequent adverse events across all the doses were somnolence, headache, decreased appetite, fatigue, nausea, and vomiting.
According to a company press release, Supernus plans to proceed with phase 3 clinical testing of SPN-812.
SAMHSA Releases MAT App For Opioid Use Disorder
The Substance Abuse and Mental Health Services Administration has released the free mobile app MATx, which provides vital information about medication-assisted treatment (MAT) for opioid use disorder.
The MATx app includes information on FDA-approved medication to treat opioid use disorders, a buprenorphine prescribing guide, and clinical support tools such as treatment guidelines, ICD-10 coding, and continuing education opportunities.
The app was developed as part of the Department of Health and Human Services’ Opioid Initiative, which was launched in March 2015 with the goals of improving opioid prescribing practices, expanding access to MAT for opioid use disorder, and increasing the use of naloxone to reverse opioid overdoses.
“There’s nothing like MATx in the field today,” Kana Enomoto, principal deputy administrator of SAMHSA, said in a press release. ■
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Published online: 1 December 2016
Published in print: November 19, 2016 – December 2, 2016
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