Purdue Pharma Announces Positive Phase 3 Clinical Trial Results of Hydrocodone Bitartrate ER Tablets
Stamford, CT – March 12, 2014 – Purdue Pharma L.P. 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 (p=0.0016). 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,” said Gary L. Stiles, MD, Purdue Pharma’s Senior Vice President of 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. The most common adverse events (≥5%) reported by patients treated with the once-daily agent were constipation, nausea, vomiting, dizziness, and headache, which are typically associated with opioid analgesics.
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.
Hydrocodone products are the most commonly prescribed opioid analgesics in the United States1. They are also the most widely abused (non-medical use), according to the Substance Abuse and Mental Health Services Administration2. Currently available hydrocodone formulations do not incorporate abuse-deterrent technologies.
About the Phase 3 Study
The double-blind, randomized, multi-center, placebo-controlled, Phase 3 study evaluated 588 opioid-naïve and opioid-experienced patients with moderate to severe chronic low back pain over a 12-week, double-blind period. Of the patients who were randomized, the weekly average pain score at study entry was 7.4 on a scale of 0 to 10 (0 = no pain and 10 =pain as bad as you can imagine). The primary endpoint measured the mean pain intensity over a 24-hour period recorded daily during the last week of the double-blind period. To achieve adequate pain control prior to randomization, the dose for hydrocodone bitartrate extended-release was increased once every 3 to 5 days, if necessary, until a stabilized once-daily dose was identified (20–120 mg).
About Chronic Pain
Purdue Pharma is a leader in developing treatment options for the management of chronic pain, which is one of the most common reasons for visits to healthcare professionals. Chronic pain conditions affect more than 100 million U.S. adults and cost the American economy as much as $635 billion each year in direct healthcare expenses and lost productivity3.
About Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.
- U.S. Pharmaceutical Sales – Q4 2013, Drugs.com, Accessed 02/28/2014
- 2012 National Household Survey on Drug Use and Health, Table 1.89A, Susbtance Abuse and Mental Health Services Administration. Accessed 02/28/2014
- Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, Institute of Medicine, June 29, 2011.
Source: Purdue Pharma L.P.
Posted: March 2014