FDA OKs new epilepsy drug for some opioid users

Drugmakers have cleared an experimental off-patent version of their anti-epileptic drug hydrocodone for prescription in the United States and Japan despite limited information about hydrocodones safety and effectiveness. The results of the study are due to be presented today at the American Academy of Neurologys 73rd Annual Meeting in Philadelphia Pennsylvania.

Hydrocodone sold under the trade name Vowrail works by blocking the opioid receptors (known as mu opioid receptors) in the brain. The drug has been used to treat non-cancer pain since the late 1990s; however exact doses have not been demonstrated. A 2016 know-how bioequivalence analysis of 25 hydrocodone formulations (when delta opioid receptors are absent) showed that the drug granted similar drug-based analgesic action as octopamine the active ingredient in many opioid pain medicines. Hydrocodone has another advantage over its competitors-it acts more quickly and safely when taken within 24 hours of being injected.

Because of these characteristics the U. S. Food and Drug Administration approved the new analysis results as well as the labeling of the formulation or formulations. The findings came as a surprise to the authors of this meta-analysis. More importantly the two studies did not report whether the findings differed in any significant way the authors explained. In particular one study of 122 polysubstance-filled hydrocodone formulations (164 formulations) compared the quality-adjusted mean (QMA) to respective values reported in the manufacturers publications. The QMA value was 2. 41 with manufacturer-reported QMA and the manufacturer-reported QMA was 8. 08 with QMA surveys.

A greater slope of opioids for current users versus those receiving hydrocodone showed no significant difference in the magnitude percentage change in palfurzione a measure of the relative frequency of binding opioid receptor (proprioceptive trial estimates mean and maximum urinary concentration of opioid receptors) in opioid analgesic formulations against pure sodium naltrexone. No significant difference in other measures was observed for hydrocodone versus octopamine formulations.

Long-term opioid intake varied between hydrocodone and both octopamine and morphine formulations with the strongest dose-effect occurring as late as 4 hours post injecting. In 89 hydrocodone formulations morphine yielded morphine at a median dose of 60 micrograms per ounce and fentanyl yielded fentanyl at a median dose of 150 micrograms per ounce.

The study therefore does not quantify the dose-effect relationship of hydrocodone versus other opioid drugs or viral analogues when taken within a prolonged period. We cannot say whether there was a dose-effect relationship in these studies because the studies were so small.

Tanzi Komarow Ph. D. coauthor and associate professor of neurology at UH.

Controlled studies are limited because results must be repeated and submitted to confirm the presence or absence of THC the psychoactive component in marijuana and other synthetic cannabinoids. Future controlled studies on hydrocodone are also of limited applicability and do not assess the 20-minute dosing of hydrocodone.

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