Med Check
FDA Approves Austedo For Treatment of TD
The Food and Drug Administration has approved Teva Pharmaceuticals’ Austedo (deutetrabenazine) tablets for the treatment of adults with tardive dyskinesia (TD). Deutetrabenazine is a small molecule vesicular monoamine 2 transporter (VMAT2) inhibitor that has FDA approval for the treatment of chorea associated with Huntington’s disease.
The approval was based in part on the results of two 12-week, randomized, double-blind, placebo-controlled, multicenter trials, which compared changes in involuntary movements in 335 TD patients who took deutetrabenazine or placebo.
In both trials, patients taking deutetrabenazine (24 mg/day to 48 mg/day) experienced statistically significant improvement in their Abnormal Involuntary Movement Scale (AIMS) score from baseline to week 12 compared with patients taking placebo.
Sunovion Submits NDA For ADHD Medication
Sunovion Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for its investigational compound dasotraline for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adults.
Dasotraline is a dual-acting dopamine and norepinephrine reuptake inhibitor with a half-life of 47 to 77 hours.
The NDA submission for dasotraline is supported by data from four placebo-controlled safety and efficacy studies, as well as two long-term, open-label safety studies, which evaluated about 2,500 patients with ADHD.
Dasotraline is also being investigated for the treatment of binge-eating disorder in adults.
Amneal Recalls 13 Lots of Oral Lorazepam Due to Dropper Defects
Amneal Pharmaceuticals is voluntarily recalling 13 lots of lorazepam oral concentrate (2 mg/mL) from the market due to a defect in the dosing droppers.
The company stated that there is no issue with the medication itself, but some of the droppers in the affected lots have marking errors. These errors include dose markings printed in reverse number order, dose markings that are shifted, or no dose markings at all.
The errors increase the risk that individuals may dispense more or less than their prescribed dose, which can lead to adverse effects including drowsiness, increased anxiety, and/or accidental injury to one’s self or others.
According to the company, recall letters and replacement droppers have been sent to all pharmacies that may have received the defective lots. A list of the 13 recalled lots can be accessed here.
Opioid-Containing Cough Medicines Not Safe For Children Under 18
An FDA advisory committee in September concluded nearly unanimously that the risks of using children’s cough medications that contain codeine or hydrocodone far outweigh the benefits.
This newest recommendation was part of the FDA’s ongoing effort to understand the potential complications that can occur when using opioid-containing medications in children.
In April, the FDA issued a warning that cough medications with codeine should not be used in children 12 and under. An advisory panel different from the initial one was considering the use of codeine or hydrocodone both in children aged 6 to 12 and adolescents aged 12 to 18.
The main concern expressed by the panel was not that children would become addicted to opioid-containing cough medicines, but that there is little evidence indicating that these medicines are effective to treat cough in children. In contrast, there is a significant body of data showing these medicines can cause serious side effects, including death.
Genetic Test May Predict Opioid Addiction Risk
A genetic test appears to be able to accurately predict whether a patient may become addicted to opioid medications, according to a study published in the Annals of Clinical and Laboratory Science in August. The test, called LifeKit Predict, uses an algorithm to calculate a patient’s addiction risk score based on 16 genetic variants in brain reward pathways.
Data from 37 patients with prescription opioid or heroin addiction and 30 age- and gender-matched controls were used to design the predictive score. An evaluation of 138 samples from patients both with and without opioid addiction showed that LifeKit Predict can identify individuals with a low likelihood of becoming addicted to opioids with 97 percent certainty. The test also showed an 88 percent likelihood of predicting that an individual has an elevated risk for opioid addiction.
“These findings confirmed what previously published data have shown—that there is a strong genetic component to opioid addiction, and with the right tools, an individual’s risk of opioid dependency can be predicted,” Keri Donaldson, M.D., founder and CEO of Prescient Medicine, said in a press release. Prescient Medicine is the developer of LifeKit Predict. ■
