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news.The US Food and Drug Administration (FDA) has accepted for review Pfizer's new drug application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride), extended-release capsules, an abuse-deterrent formulation (ADF) opioid for the management of pain.
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The drug is indicated to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
ALO-02 is an extended-release oxycodone developed to reduce abuse via the oral, intranasal and intravenous (IV) routes when crushed.
The NDA is based on the data from two Phase III trials in patients with moderate-to-severe, non-cancer chronic pain.
Additionally, the company had conducted three abuse-potential trials in recreational opioid users, comparing the abuse potential of crushed ALO-02 with immediate-release oxycodone when taken by the oral, intranasal or intravenous routes.
The company said that the combination of oxycodone and 12% naltrexone was used to simulate crushed ALO-02 in the IV study.
ALO-02 capsules contain pellets that include extended-release oxycodone hydrochloride, an opioid agonist, which surround sequestered naltrexone hydrochloride, an opioid receptor antagonist.
In 2013, around 10 million US adults reported prescription pain reliever use for non-medical purposes in the previous year, according to the National Survey on Drug Use and Health.
The company believes that abuse deterrent formulation opioids, including ALO-02, are an important step toward helping to address the growing public health issue of opioid abuse in the US.
Image: Pfizer world headquarters. Photo: courtesy of Jim.henderson.