FDA approves first non-opioid to treat withdrawal symptoms in adults
FDA approves first non-opioid to treat withdrawal symptoms in adults
FDA OKs first non-opioid treatment for opioid withdrawal
18 May, 2018, 03:57
"We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction", FDA Commissioner Scott Gottlieb, MD, said in the agency's announcement.
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. The symptoms can inflict patients who are using opioids as instructed by a physician, and those patients who are addicted to it.
"It won't completely eliminate symptoms of withdrawal", Mark Pirner, the senior medical director at Lucemyra manufacturer US WorldMeds, tells STAT News. In as little as a few hours, patients may experience stomach cramps, muscle aches and spasms, a pounding heart, nausea, vomiting and diarrhea. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help.
The FDA says that Lucemyra decreases the release of norepinephrine, a chemical that mobilizes the body for action. Lucemyra (lofexidine hydrochloride) has been approved by the U.S. Food and Drug Administration to treat symptoms of opioid withdrawal.
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To test the drug, researchers conducted a pair of random clinical trials. Adverse side effects included low blood pressure or symptoms such as lightheadedness, slow heart rate, dizziness, sleepiness, feeling faint at rest or when standing up, and dry mouth, said the release. Each of the symptoms were rated by the patients as either "none, mild, moderate and severe". Compared to the placebo group, patients treated with Lucemyra reported a lower severity of symptoms. It is not yet declared safe in children and adolescents up to the age of 17 years. An advisory committee this March had approved Lucemyra and had advised the FDA accordingly. Lucemyra, FDA noted, is only approved for treatment up to 14 days and is to be used as part of a broader, long-term treatment plan for managing opioid use disorder.
The FDA requires a further 15 postmarketing studies to check for the safety of the drug.
As a major aspect of the U.S. Bureau of Health and Human Services' Five-Point Strategy to Combat the Opioid Crisis, the FDA stays focused on tending to the national emergency of opioid compulsion on all fronts, with a critical spotlight on diminishing presentation to opioids and averting new enslavement; supporting the treatment of those with opioid utilize scatter; cultivating the advancement of novel torment treatment treatments and opioids more impervious to manhandle and abuse; and making a move against the individuals who add to the unlawful importation and offer of opioid items.
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