Med Check
Passes Phase 3 Test in Youth
Sunovion Pharmaceuticals in April reported positive results from the phase 3 study of dasotraline—a dopamine and norepinephrine reuptake inhibitor (DNRI)—in children with attention-deficit/hyperactivity disorder (ADHD).
For the trial, 112 children aged 6 to 12 were randomized to receive 4 mg of dasotraline or placebo daily and evaluated on classroom performance over 15 days. The primary outcome was change in the Swanson, Kotkin, Agler, M-Flynn, and Pelham combined score (SKAMP-CS), a validated rating scale for measuring functional impairment in classroom settings.
The children taking dasotraline showed statistically significant improvements in overall SKAMP-CS as well as the SKAMP subscales of attention and deportment compared with placebo. These improvements were evident at multiple times over the course of the day (12 to 24 hours post-dose).
Dasotraline was also well tolerated, with insomnia, decreased appetite, and headache among the most commonly reported adverse events.
Sunovion plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) for dasotraline for the treatment of ADHD by March 2018, according to a company press release.
FDA Issues New Warnings on Codeine/Tramadol Use in Children
In an effort to restrict the prescribing of tramadol and codeine to children, the FDA in April announced the following labeling changes:
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Labels will now feature a contraindication warning that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than age 12. In addition, the tramadol label will feature a contraindication warning against the use of the medication in children younger than 18 to treat pain after tonsil/adenoid removal.
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The labels will also feature a warning, recommending against the use of either drug in adolescents between 12 and 18 years who have conditions that increase the risk of breathing problems, such as obesity, sleep apnea, or severe lung disease.
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Both medications will feature a strengthened warning that breastfeeding is not recommended for mothers taking codeine or tramadol due to the risk of serious adverse reactions in breastfed infants, including excess sleepiness and serious breathing problems.
A boxed warning cautioning against prescribing codeine to treat pain after tonsil or adenoid surgery is already featured on the medication. Additionally, both opioids have warnings about the risk of serious breathing problems in some children who metabolize codeine and tramadol faster than usual (called ultra-rapid metabolism).
Shortages Expected for Pernix’s Controlled-Release Hydrocodone
Pernix Therapeutics, maker of Zohydro ER (hydrocodone), announced last month that due to a manufacturing problem, the 20-mg strength version of the medication is not available. Zohydro ER is a controlled-release, tamper-resistant opioid pain medication.
The company said in a statement that it expects the 20-mg version of this drug will be on backorder until early 2018. Zohydro will continue to be available in the other strengths, including 10 mg, 15 mg, 30 mg, 40 mg, and 50 mg strengths, but Pernix anticipates that as doctors who were prescribing 20-mg doses switch to other strengths, there may be other shortages.
Pernix said it is evaluating what the “scope of any potential impact” might be and will provide updates as new information emerges. The company also said it is working with its supplier to ensure the return of the 20-mg strength to the marketplace as soon as possible.
FDA to ‘Fast Track’ NMDA Antagonist for MDD
Relmada Therapeutics Inc. in April announced that the FDA has granted a Fast Track designation to REL-1017 (dextromethadone)—a NMDA receptor antagonist—for the adjunctive treatment of major depressive disorder. Drugs that receive a Fast Track designation receive accelerated reviews and priority approval to speed their development.
Dextromethadone, or d-methadone, is an enantiomer (mirror image) of methadone that primarily blocks N-methyl-D-aspartate (NMDA) receptors, which are linked with both depression and neuropathic pain. However, no currently approved drugs to treat depression target NMDA receptors.
Relmada has completed multiple phase 1 studies for REL-1017 that confirmed safety, tolerability, and effective dose range. They are now planning a phase 2a randomized, placebo-controlled study in patients with major depressive disorder. ■
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Published online: 1 June 2017
Published in print: May 20, 2017 – June 2, 2017
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