FDA approves first non-opioid withdrawal treatment

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".

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

Common symptoms of opioid withdrawal include nausea, muscle cramping, agitation, anxiety, and opiate cravings.

"We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction", said FDA commissioner Scott Gottlieb in a statement.

"Lucemyra presents an important new tool to help people make it successfully through withdrawal, which is very often critical for linking to ongoing continuing care and next steps in treatment for opioid dependence or addiction", said Marc Fishman, MD, medical director, Maryland Treatment Centers and assistant professor, Johns Hopkins University School of Medicine.

Lucemyra (lofexidine hydrochloride) was originally meant to be a hypertension drug.

Lofexidine is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. In two randomized, double-blind, placebo-controlled trials, 866 adult patients demonstrated the benefits and safety of the drug. The approved treatment period is up to 14 days. This committee received public input from patients who use opioids to manage their chronic pain. Extra creature security studies will be required to help longer-term utilize, (for example, amid a progressive opioid decrease in torment patients stopping opioid analgesics) and use in youngsters. 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.

The FDA approved the first non-opioid medication to treat opioid withdrawal in adults, in order to "facilitate abrupt discontinuation of opioids in adults", the agency said Wednesday. The guidelines were not well received by patients, who said the guidelines led to less doctors prescribing opioids for their pain.

Side effects of the treatment included low blood pressure, dizziness, sleepiness, slow heart rate, and a few cases of syncope (fainting). It is not yet declared safe in children and adolescents up to the age of 17 years. The approval for making the drug is granted to US WorldMeds LLC. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.