Purdue Pharma to file NDA for abuse deterrent formulation of hydrocodone bitartrate

STAMFORD, Conn. — Purdue Pharma recently announced that a Phase 3 study of an investigational extended‐release formulation of hydrocodone bitartrate met its primary efficacy endpoint by showing that patients with chronic low back pain treated with the once‐daily analgesic agent experienced statistically significant reduction in pain compared with placebo. 

This investigational single‐entity opioid analgesic formulation incorporates abuse deterrent properties intended to make the tablets more difficult to manipulate for the purpose of misuse and abuse by various routes of administration (e.g., snorting and intravenous injection).

“We are very encouraged by the results of this pivotal study,” stated Gary Stiles, Purdue Pharma SVP research and development. “This is another step forward in our efforts to develop therapeutic options for use by chronic pain patients that are designed to be unattractive to drug seekers.” 

In the study, the majority of patients treated with hydrocodone bitartrate dosed once‐daily experienced at least a 30% improvement in pain intensity. Nearly half of patients (48%) achieved a 50% improvement with hydrocodone bitartrate. 

In addition to this safety and efficacy study, Purdue Pharma has conducted a series of laboratory manipulation and extraction studies, pharmacokinetic studies and clinical abuse potential studies with this investigational medication. The company plans to file a New Drug Application with the FDA later in 2014 requesting approval to market the medication.

Currently available hydrocodone formulations do not incorporate abuse‐deterrent technologies, Purdue Pharma noted.