Hydrocodone bitartrate (Hysingla ER, Purdue Pharma) extended-release tablets CII is now commercially available.
Hydrocodone bitartrate (Hysingla ER, Purdue Pharma) extended-release tablets CII is now commercially available. The drug is the first and only hydrocodone product to be recognized by FDA as having abuse-deterrent properties that are expected to deter misuse and abuse via chewing, snorting and injection. However, abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible.
Hysingla ER was approved by FDA with labeling describing its abuse-deterrent properties that is consistent with the FDA’s 2013 Draft Guidance on AbuseâDeterrent Opioids: Evaluation and Labeling.
Hydrocodone combination products are among the most prescribed opioids in the United States, accounting for 120 million prescriptions in 2014. Hydrocodone is the most commonly abused opioid, according to federal surveys.
Once-daily Hysingla ER is available in 7 dosing strengths: 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg. The drug does not contain a non-steroidal anti-inflammatory drug (NSAID) or acetaminophen. It is formulated with Resistec technology, a proprietary extended-release solid oral dosage platform that uses a unique combination of polymer and processing that confers tablet hardness and imparts viscosity when dissolved in aqueous solutions.
“Hysingla ER is priced competitively and in line with other brand name, extended-release products currently available,” according to J. David Haddox, MD, vice president, health policy of Purdue Pharma. “To date, 80% of commercially insured lives have access to Hysingla ER through their health plans. To support patient access, Purdue is offering a patient trial card and copay support programs for eligible patients.”
FDA’s approval was based on a pivotal phase 3 study met its primary efficacy end point by showing that patients with chronic low back pain treated with Hysingla ER tablets experienced statistically significant reduction in their weekly average pain score at week 12, compared to those randomized to the placebo arm. In the study, 65% of patients treated with the Hysingla ER tablets experienced at least a 30% reduction in pain intensity at week 12 compared to 53% of patients in the placebo group. Nearly half of patients (48%) achieved at least a 50% reduction in pain intensity with Hysingla ER tablets versus 39% of patients randomly assigned to the placebo arm.