ibusinesslines.com August 21, 2018

FDA greenlights Louisville company's drug for opioid withdrawal

18 May 2018, 03:59 | Melissa Porter

Robert F. Bukaty AP

Robert F. Bukaty  AP

It reduces the release of norepinephrine, a hormone believed to play a key role in triggering withdrawal symptoms.

The FDA still wants Lucemyra to conduct some safety studies to see the effects on children.

"As part of our commitment to support patients struggling with addiction, we're dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids", said FDA Commissioner Scott Gottlieb, MD, in an agency release. Less common reactions could include fainting and abnormal heart rhythms. The wellbeing and viability of Lucemyra have not been built up in kids or young people under 17 years old. Patients' symptoms were evaluated according to the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), which included feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia/problems sleeping.

"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help".

On May 16, the Food and Drug Administration (FDA) approved of the first non-opioid treatment for adults suffering from opioid withdrawal symptoms. The treatment is to be provided only for 14 days. And those who seek assistance may relapse due to continued withdrawal symptoms.

The FDA is considering coming up with a strategy in the next few months to encourage medical professional societies to create evidence-based guidelines on how to prescribe medications for acute medical needs and assess prescribing behavior as well as adding new prescribing information to opioid labels.

The FDA requires a further 15 postmarketing studies to check for the safety of the drug.

For patients using opioids appropriately, withdrawal is usually managed by slow reduction in doses.

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". Patients can experience any combination of these symptoms after ceasing opioid use.

Lucemyra (lofexidine hydrochloride), therefore, represents a win for both the agency and US WorldMeds, which has just a handful of marketed products.

The FDA granted Lucemyra the go-ahead after previous priority review and fast track designations, and it comes after an independent scientific panel voted 11-1 in favor of its approval.

Because Lucemyra can make withdrawal process easier for patients, National Institute on Drug Abuse Director Nora Volkow, M.D., argues it could boost wider use of Vivitrol, which differentiates itself from methadone and buprenorphine, two other addiction treatments that belong to the opioid family.

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