Purdue Pharma has obtained approval from the US Food and Drug Administration (FDA) for the launch of a new 15mcg/hr dosage strength of Butrans (buprenorphine) Transdermal System CIII.
Following the approval, Butrans will be available in four strengths including the 5, 10, 15 and 20mcg/hr.
The company expects to commercially launch the enhanced dosage strength of Butrans in the US during October 2013.
Purdue Pharma MD Gary Stiles said that the approval of Butrans 15 mcg/hr dosage offers healthcare professionals added flexibility when using Butrans for the management of moderate to severe chronic pain.
"The new strength provides another option when adjusting the dose to obtain an appropriate balance between adequate pain relief and opioid-related adverse reactions," Stiles added.
According to the company, Butrans is the first transdermal system that delivers a continuous release of buprenorphine for seven days.
It comprises of the active ingredient buprenorphine, a partial agonist at mu opioid receptor, and a Schedule III controlled substance.
Butrans is developed for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgaesic is needed for an extended period of time.
