Purdue Pharma L.P. has developed an abuse-resistant drug to treat chronic low back pain.
An abuse-resistant opioid analgesic, hydrocodone bitartrate, has been successfully developed to combat chronic low back pain, according to a statement from Purdue Pharma L.P.
In a phase 3 study, scientists evaluated 588 opioid-naïve and opioid-experienced patients with moderate to severe chronic low back pain for 12 weeks. The weekly average score for pain was 7.4 on a scale of 0-10 (10 being maximum pain). The drug dosage was increased once every 3-5 days if necessary until a stabilized once-daily dose was identified (20-120 mg).
A majority of the study’s participants demonstrated at least a 30% improvement of pain intensity and almost half of patients reached 50% improvement. Common side effects after taking the drug were common opioid analgesic side effects including constipation, nausea, vomiting, dizziness, and headache.
Hydrocodone bitartrate contains properties intended to make the tablets harder to manipulate for snorting and intravenous injection purposes.
Purdue Pharma intends to file a New Drug Application with the US Food and Drug Administration later in 2014 requesting approval to market the drug.