Over a year ago, the FDA created the Opioid Policy Steering Committee with the goal of reducing exposure to opioids, preventing more addictions and developing and cultivating the use of medications to treat opioid addiction.
The approval of Lucemyra was based on 2 randomized, double-blind, placebo-controlled clinical trials (N=866) of adults with opioid dependence who were physically dependent on opioids and undergoing abrupt opioid cessation.
For those addicted to opioids, quitting cold turkey can be a harrowing experience. Some patients experience mental side effects like anxiety and agitation, while others have physical ailments like vomiting and drug craving. These symptoms include feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia/problems sleeping.
For patients using opioids appropriately, withdrawal is usually managed by slow reduction in doses.
Gottlieb said the FDA wants to "strike the right balance" between making policies that give patients who need opioids the proper accessibility and preventing opioid exposures that lead to new addictions.
Lucemyra suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal.
Lofexidine Hydrochloride, also referred to as the brand name Lucemyra, is now FDA Approved.
Lucemyra is an orally available alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, a neurotransmitter that plays a key role in many opioid withdrawal symptoms. SOWS-Gossop scores were lower for patients treated with Lucemyra compared to placebo, and more patients completed the treatment period of the studies in the Lucemyra group compared to placebo. Lucemyra isn't a treatment for opioid utilize clutter (OUD), however, can be utilized as a feature of a more extensive, long haul treatment get ready for overseeing OUD.
For each withdrawal symptom, patients were asked to rate the severity using 4 response options (none, mild, moderate and severe) with the SOWS-Gossop total score ranging from 0-30-a higher score indicated a greater withdrawal symptom severity.
The Food and Drug Administration (FDA) has approved the first non-opioid therapy for the management of opioid withdrawal symptoms.
Patients with chronic pain can attend the FDA's "Patient-Focused Drug Development for Chronic Pain" meeting on July 9 from 10 a.m.to 4 p.m. Patients can attend in person in Maryland or through a webinar by registering online.
The FDA allowed this application Priority Review and Fast Track assignments, and an autonomous FDA warning board bolstered the endorsement of Lucemyra at a gathering held March. The approval for making the drug is granted to US WorldMeds LLC.