Saturday, 26 May, 2018

FDA approves drug to help with opioid withdrawal symptoms

FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults FDA OKs first non-opioid treatment for opioid withdrawal
Samantha Long | 17 May, 2018, 12:23

The FDA said that Lucemyra is only approved for up to 14 days.

Federal regulators on Wednesday approved the first nonopioid treatment to ease withdrawal from quitting addictive opioids. The drug, called Lucemyra (lofexidine hydrochloride), will also help adults who rely on opioids for pain relief.

"We've heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life", Gottlieb wrote.

The medication may lessen the severity of withdrawal symptoms but not completely eliminate them. The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal. The wellbeing and adequacy of Lucemyra was upheld by two randomized, twofold visually impaired, fake treatment controlled clinical trials of 866 grown-ups meeting Diagnostic and Statistical Manual-IV criteria for opioid reliance who were physically subject to opioids and experiencing unexpected opioid end. Some patients received Lucemyra, and some patients received a placebo.

For each opioid withdrawal symptom, patients are asked to rate their symptom severity using four response options (none, mild, moderate and severe), with the SOWS-Gossop total score ranging from 0 to 30, where a higher score indicates a greater withdrawal symptom severity.

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Side effects included low blood pressure, dizziness, sleepiness, slow heart rate and, in a few people, fainting. Lucemyra was additionally connected with a couple of instances of syncope (blacking out).

We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs. Extra creature security studies will be required to help longer-term utilize, (for example, amid a progressive opioid decrease in torment patients stopping opioid analgesics) and use in youngsters. Clinical studies will be required to evaluate the safety of Lucemyra in clinical situations where use could be expected to exceed the maximum 14-day treatment period for which the product is now approved, such as gradual opioid taper; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after lofexidine is stopped.

Over a year ago, the FDA created the Opioid Policy Steering Committee with the goal of reducing exposure to opioids, preventing more addictions and developing and cultivating the use of medications to treat opioid addiction. There are several drugs on the market that can be used to treat the overall disorder, but some of them are hard to access.

Privately held US WorldMeds said it had not yet set a price for Lucemyra.

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