FDA approves first non-opioid drug to treat opioid withdrawal symptoms

Postado Mai 17, 2018

The Food and Drug Administration on Wednesday approved use of the drug Lucemyra, saying it gives doctors a new option for treating the side effects of withdrawal.

Those symptoms include anxiety, muscle aches, sweating, vomiting and a craving for drugs. "The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that's sometimes associated with the use of medication-assisted treatments".

The medication may lessen the severity of withdrawal symptoms but not completely eliminate them.

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

Opioids are synthetic painkillers generally prescribed by doctors or used in hospital emergency rooms.

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

Lucemyra is not a treatment for opioid use disorder (OUD), but can be used to manage OUD as part of a long-term plan, the drugs regulator said. It has been approved for patients to use up to 14 days.

The FDA is requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct safety studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids. Clinical studies will be required to evaluate the safety of Lucemyra in clinical situations where use could be expected to exceed the maximum 14-day treatment period for which the product is now approved, such as gradual opioid taper; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after lofexidine is stopped.

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.

The application was granted priority review and fast track designations, and an independent FDA advisory committee supported the approval of Lucemyra at a meeting held in March.

Opioids were involved in more than 42,000 overdose deaths in 2016, the previous year for which data was available, according to the U.S. Centers for Disease Control and Prevention.