Friday, 21 September, 2018

FDA approves first non-opioid treatment for opioid withdrawal - 3 insights

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
Johnnie Parks | 18 May, 2018, 03:56

The FDA approves privately held US WorldMeds LLC's Lucemyra (lofexidine hydrochloride) for the management of opioid withdrawal symptoms in adults who abruptly discontinue opioids.

"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 says in the statement.

The FDA noted that while Lucemyra can reduce withdrawal symptoms, it has not been confirmed to prevent them, and that the treatment should not continue beyond 14 days.

While there are now some other approved drugs that mitigate withdrawal symptoms, many are themselves opioids, such as buprenorphine, or target specific symptoms alongside underlying opioid dependency.

"There are many people who are physically dependent, meaning if you stop it, you're going to get withdrawal symptoms", but those people may not be to the point of negative social behavior, such as stealing things or ruining relationships, said Dr. Mark Pirner, senior medical director of Clinical Research and Medical Affairs for US WorldMeds.

At present the medications used in treatment of withdrawal symptom prevention include methadone, naltrexone, buprenorphine etc.

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The federal government and Congress are grappling with how to stem the tide of the opioid epidemic, which has shown no signs of slowing down and is contributing to an estimated 115 American deaths per day.

Manufacturer US WorldMeds said it will market the drug as soon as this summer, under the trade name Lucemyra. Compared to the placebo group, patients treated with Lucemyra reported a lower severity of symptoms. Each of the symptoms were rated by the patients as either "none, mild, moderate and severe".

The new compound itself is not without side effects; Lucemyra can cause dizziness as well as low blood pressure and heart rate. Less common reactions could include fainting and abnormal heart rhythms.

New medication targets symptoms experienced when reducing or stopping opioids due to physical dependence.

The safety and efficacy of Lucemyra have not been established in children or adolescents under age 17. For these individuals, to avoid symptoms medications need to be tapered slowly. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren't over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.

US WorldMeds - a former Vogt Award victor in Louisville - "has been developing the data needed for FDA approval for over 10 years", he said, adding, "Being a Louisville-based company is a main priority and one of the core mission visions of US WorldMeds".

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