FDA approves drug to help with opioid withdrawal symptoms

FDA approves drug to help with opioid withdrawal symptoms

The Food and Drug Administration gave a green light to the first non-opioid drug aimed at controlling the withdrawal symptoms associated with opioid use.

For those addicted to opioids, quitting cold turkey can be a harrowing experience.

The studies evaluated benefit using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) to assess opioid withdrawal symptoms that included feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia. Thus far, patients with OUD have managed withdrawal by.

Gottlieb said fear of withdrawal often discourages those with a physical dependence from seeking treatment, and the potentially intense symptoms often contribute to relapses.

Gottlieb also said the FDA will be developing guidance documents for the most efficient path for developing drugs that can be used to treat various types of pain. It reduces the release of norepinephrine, a hormone believed to play a key role in triggering withdrawal symptoms. 866 adults participated in the study. Compared to the placebo group, patients treated with Lucemyra reported a lower severity of symptoms.

The drug Lucemyra reduces the severity of withdrawal symptoms but can not eliminate them altogether. The agency added that it's requiring 15 additional studies in both people and animals to evaluate factors such as longer-term use and the drug's effects on the liver. Additionally, the therapy has not been approved to treat opioid use disorder, but is meant to be used as part of a long-term treatment plan for the condition. Other treatments may also be prescribed by a patient's health care provider.

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"Which is why patients may often not be able to go through the process without being an inpatient".

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. Common side effects include a slow heart rate, low blood pressure, and sleepiness.

The safety and efficacy have not been established in children or adolescents 17 years of age and younger.

"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.

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.

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