Penwest nalbuphine ER analgesic reduces pain during phase 2a study

By Angela McDaniels

Seattle, Feb. 10 - Penwest Pharmaceuticals Co.'s nalbuphine ER (PW4142) analgesic reduced pain intensity in a dose-dependent manner during a phase 2a clinical trial, according to a company news release.

Pain reduction was greater than a placebo after 90 minutes for a higher dose of nalbuphine ER and at six hours for a lower dose and was maintained at all time points over the remaining 12-hour dosing interval.

Positive results were also observed in the proportion of patients requiring additional analgesics during the 12-hour study period for both the low and high nalbuphine ER doses when compared to a placebo, the company said.

Finally, the percentage of patients experiencing at least a 50% reduction in pain intensity during the 12-hour study period was higher for patients treated with nalbuphine than those who received a placebo, and no unusual side effects were reported during the 12-hour dosing interval.

The 165-patient phase 2a trial was designed to determine the degree and duration of pain relief of two different dose levels of nalbuphine ER, according to the release.

Patients had a molar tooth extracted, a procedure Penwest said is commonly used as a clinical pain model for evaluating the acute effectiveness of analgesics. Patients who experienced at least a score of four on the zero to 10 NPRS pain scale following completion of their dental procedures were given blinded nalbuphine ER or a placebo as a single dose.

The company said pain relief was then evaluated at pre-specified intervals over the 12-hour period following dosing, and blood samples were also collected for 24 hours post-dose to determine plasma concentrations of nalbuphine ER.

Nalbuphine ER, a controlled release formulation of nalbuphine hydrochloride that the company said it developed using its Geminex dual-drug delivery technology, is designed to be taken as a tablet twice daily. This formulation of nalbuphine ER will have both immediate release and controlled release properties.

Nalbuphine hydrochloride is a synthetic opioid agonist-antagonist analgesic and is only available as a sterile solution suitable for injection under the brand name Nubain and as a generic. Despite the limits of currently available formulations and indications, annual sales of this product reach $10 million, according to the release.

The company said that nalbuphine ER, if approved, would compete in the moderate to moderately severe pain market with drugs such as Tramadol.

Penwest is a pharmaceutical company based in Danbury, Conn., that uses oral drug delivery technologies to develop products for the treatment of central nervous system disorders.

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