Endo To Launch Opana ER Oxymorphone With Two Risk Management Programs

The firm will add 220 sales reps to support the July launch of the extended-release and immediate-release opioid analgesics.

Endo's launch of Opana (oxymorphone hydrochloride) extended-release and immediate-release opioid analgesic tablets in July will include two risk management initiatives, the company said June 23.

The firm's recently developed PROMISE (Partnership for Responsible Opioid Management through Information, Support and Education) initiative is "a comprehensive program of practical clinical information, educational resources and patient support tools, all focused on addressing the appropriate use of opioid analgesics and minimizing the inherent risks of misuse, abuse, and diversion of these products," Endo CEO Peter Lankau said during a conference call announcing NDA approval of Opana and Opana ER .

Endo also developed a risk minimization action plan in consultation with FDA that "includes key elements like appropriate drug labeling, strong educational initiatives regarding proper prescribing, patient selection and clinical use of opioid analgesics, controls on distribution, and tracking and monitoring of reports of non-medical uses," Lankau noted.

Like all opioids, labeling for Opana includes a "black box" warning regarding use of the drug with alcohol.

In anticipation of the launch, Endo is ramping up its sales force. The firm will hire 220 new sales reps, to be distributed between specialty and primary care teams, bringing its total sales force to 590 reps, Lankau said.

"The vast majority actually of presentations [to physicians] in the first half of this launch phase - this next six months - will have Opana ER in the primary selling position," he said.

However, hiring additional reps will allow the company "to maintain a constant level of primary detailing equivalence" for other pain medications like Lidoderm (lidocaine patch 5%) and Frova (frovatriptan succinate tablets), Lankau added.

Opana will be priced comparably to branded opiates such as " OxyContin and related products," according to Lankau.

The firm will immediately "start to seek formulary acceptance for Opana and Opana ER," he stated. "We expect, based on our previous research and discussions with various managed care organizations, that the product will typically be placed in the third tier."

However, Endo said it does not expect a negative impact on sales from a tier three placement.

"Prior research has indicated no significant shift at all between market share or drug utilization between tier two and tier three, so we're quite comfortable that in many cases tier three will be sufficient," Lankau maintained.

Immediate-release Opana is indicated for relief of moderate-to-severe acute pain and will be available in 5 mg and 10 mg tablets.

Opana ER is indicated for treatment of "moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time," Endo said. The product will be available in 5 mg, 10 mg, 20 mg and 40 mg tablets.

Opana ER was developed using Penwest Pharmaceuticals' time-release technology; however, Penwest withdrew financial support of the program three years ago, Endo noted.

Penwest "continues to elect not to fund Opana ER. Therefore, Endo will recognize 100% of the losses attributable to Opana ER during its launch phase," CFO Jeffrey Black explained.

However, "Endo expects to recover Penwest's share of these losses from the future profits of Opana ER, which will be recognized as an increased share of the profits at that time."

The June 22 approval of Opana and Opana ER was based on additional data from studies the company conducted in response to 2003 "approvable" letters for the drugs (¹ (Also see "Endo Submits "Complete Response" For Oxymorphone ER" - Pink Sheet, 22 Dec, 2005.)).

The firm also plans to re-launch its injectable oxymorphone, Numorphan , under the Opana trade name in hospitals this fall, Lankau noted.

-Brooke McManus