FDA approves first non-opioid to treat withdrawal symptoms

18 May, 2018, 09:28 | Author: Joy Garcia
  • FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

But it can be used as part of a long-term plan for quitting the powerful painkillers and staying opioid-free long-term, the FDA said.

"A better understanding of opioid withdrawal represents an opportunity in the prevention, treatment and recovery process for physical opioid dependence and opioid use disorder", co-author, Mark Pirner, MD, PhD, Senior Medical Director, Clinical Research and Medical Affairs, US WorldMeds, previously told MD Magazine. These symptoms may include aches/pains, muscle spasms/twitching, stomach cramps, muscular tension, heart pounding, insomnia/problems sleeping, feelings of coldness, runny eyes, yawning and feeling sick.

Historically, opioid withdrawal is managed by substituting a different opioid and slowly reducing the dosage over time.

"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", Gottlieb said in a press release. 866 adults participated in the study. Results showed that SOWS-Gossop scores were lower in patients who are treated with Lucemyra compared to placebo. Plus, more patients in the Lucemyra arm completed a seven-day opioid discontinuation treatment. Additional animal safety studies will be required to support longer-term use (such as during a gradual opioid taper in pain patients discontinuing opioid analgesics) and use in children. The treatment is to be provided only for 14 days.

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Symptoms of opioid withdrawal vary. Also, the patient may be more sensitive to the effects of lower amounts of opioids, so they could overdose or die if they go back to using opioids to the extent that they did before they stopped using opioids.

THURSDAY, May 17, 2018 (HealthDay News) - Lucemyra (lofexidine hydrochloride) has been approved by the U.S. Food and Drug Administration to treat symptoms of opioid withdrawal. The guidelines were not well received by patients, who said the guidelines led to less doctors prescribing opioids for their pain. Concentrates in pediatric patients will incorporate investigations of babies with neonatal opioid withdrawal and investigations of various age gatherings of youngsters who have opioid withdrawal identified with ceasing therapeutically recommended opioid drugs.

The FDA granted this application Priority Review and Fast Track designations, and an independent FDA advisory committee supported the approval of Lucemyra at a meeting held March.

As part of a strategy to fight the crisis, the FDA said it's working to decrease opioid exposure to prevent new addictions and punish those who contribute to illicit opioid distribution. The organization likewise is in charge of the wellbeing and security of our country's sustenance supply, beauty care products, dietary supplements, items that emit electronic radiation, and for directing tobacco items.

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