FDA approves abuse-deterrent Oxycodone hydrochloride and Naltrexone hydrochloride extended-release capsules for management of severe pain
Oxycodone hydrochloride and Naltrexone hydrochloride is an extended release, abuse-deterrent, narcotic analgesic formulation for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment.
Recently it has been declared that US Food and Drug Administration (FDA) has approved an oral, abuse-deterrent, extended-release (ER) formulation of oxycodone hydrochloride and naltrexone hydrochloride for severe pain when other treatment options are not successful or tolerated.
Earlier, pellet of an ER oxycodone was prescribed that surrounds a naltrexone core by the name of ALO-02. But If the pellet is crushed, the naltrexone can counteract the oxycodone's effects.
It was prescribed officially for the management of pain severe enough for the daily requirement as long term opioid treatment and for which alternative treatment options are inadequate.
However, it is contraindicated for patients with significant respiratory depression, gastrointestinal obstruction and severe bronchial asthma in certain situations. Nausea, constipation and vomiting were the most common adverse events that were reported.
For recommendation of approval, a joint meeting was held in June of FDA's Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and its Drug Safety and Risk Management Advisory Committee (DsaRM) panels voted 9 to 6 for it.
They also voted 9 to 6 that abuse-deterrent labeling should be included regarding the intravenous abuse routes and voted 11 to 4 for labeling about intra-nasal routes. However, the outcome vote was only 6 to 9 regarding oral route labeling.
Earlier, Medscape Medical News reported that AADPAC and DsaRM voted overwhelmingly (18 to 1) for recommending the approval of the abuse-deterrent morphine product known as Arymo ER (Egalet Corp) for the same indication.
To make chewing or crushing difficult, the tablet was designed dense or hard but it turns to gel when combined with a liquid to deter injection. At the meeting, the joint panel voted 18 to 1 that Arymo ER should have abuse-deterrent labeling for nasal and intravenous routes and voted 16 to 3 that it should also mention oral abuse deterrence.
However, the final decision is to be taken by the FDA for the drug and is to be announced in October.