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Positive Phase III Results Reported for Extended-Release Hydrocodone Bitartrate
A phase III study of an investigational extended-release formulation of hydrocodone bitartrate (Purdue Pharma) has met its primary efficacy endpoint by showing that patients with chronic low back pain treated with the once-daily analgesic agent experienced a statistically significant reduction in pain compared with those given 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).
In the new study, most of the patients treated with hydrocodone bitartrate dosed once-daily experienced at least a 30% improvement in pain intensity. Nearly half of the patients (48%) achieved a 50% improvement.
The most common adverse events reported by patients treated with the once-daily agent were constipation, nausea, vomiting, dizziness, and headache, which are typically associated with opioid analgesics.
The double-blind, randomized, placebo-controlled, phase III study evaluated 588 opioid-naïve and opioid-experienced patients with moderate-to-severe chronic low back pain over a 12-week period. 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 before randomization, the dose for extended-release hydrocodone bitartrate was increased once every 3 to 5 days, if necessary, until a stabilized once-daily dose (20 to 120 mg) was identified.
In addition to this safety and efficacy study, a series of laboratory manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential studies have been conducted with the extended-release formulation of hydrocodone bitartrate. A new drug application (NDA) is expected to be filed with the FDA later this year.
Hydrocodone products are the most commonly prescribed opioid analgesics in the U.S. They are also the most widely abused (non-medical use), according to the Substance Abuse and Mental Health Services Administration. Currently available hydrocodone formulations do not incorporate abuse-deterrent technologies.
Chronic pain is one of the most common reasons for visits to health care 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 health care expenses and lost productivity.
Source: Purdue Pharma; March 12, 2014.