Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. announced that the US Food and Drug Administration (FDA) has granted final approval of the company's New Drug Applications (NDAs) for its extended- release and immediate-release formulations of oxymorphone hydrochloride. These products are now known under the trade names Opana ER tablets and Opana tablets.
A new oral extended-release opioid analgesic option for patients, Opana ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time and is not intended to be used on an as-needed basis. This is the first time oxymorphone will be available in an oral, extended-release formulation. Opana ER will be available in 5mg, 10mg, 20mg and 40mg tablets. Opana (the immediate release version) is indicated for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate and will be available in 5mg and 10mg tablets. Both products are expected to be commercially available in the US in the coming weeks. Endo also plans to re- launch its oxymorphone hydrochloride injection under the new trade name in the hospital setting.
Peter A. Lankau, president and chief executive officer, said, "We are pleased with the approval of Opana ER and Opana, which represent Endo's first internally developed NDAs to be granted FDA approval. The clinical programme for Opana ER and Opana represents one of the most comprehensive ever conducted for an opioid analgesic, with more than 15 clinical trials enrolling over 3,000 patients. Further, Endo is very excited to be able to provide physicians and patients with these important new options for pain management."
Lankau added, "As a market leader in pain management, Endo is committed to the appropriate use of opioids, and we have worked closely with the FDA and external consultants to develop a program that gives health care providers and patients essential information and guidance on responsible opioid use."
Opana ER will compete in the market for long-acting, strong opioid analgesics, a $3.2 billion market in 2005. Its clinical profile demonstrates it can be dosed consistently on a twice-daily basis and is well-tolerated when titrated effectively. Opana ER has also demonstrated maintenance of effective pain control at a stable dose over the three-month period of the pivotal clinical trials, which the company believes highlights the durability of its analgesic effect. Experts agree that patients suffering from moderate- to-severe chronic pain which is present much or all of the day need around- the-clock coverage with an analgesic agent to sustain pain relief. Opana ER utilizes a patented delivery system that was specifically developed to provide continuous delivery of medication over a 12-hour period, helping patients maintain a steady level of pain relief. Opana ER and Opana were both formulated using oxymorphone hydrochloride, which had been available only as an injectable formulation. Both products have been proven to achieve effective relief in multiple moderate-to-severe pain models, in both opioid- naïve and opioid-experienced patients.
"The availability of Opana ER is great news for physicians as it adds to the arsenal of chronic pain management tools," said Richard Rauck, M.D., Clinical Associate Professor in the Department of Anesthesiology at Wake Forest University School of Medicine and Medical Director of the Center for Clinical Research in Winston-Salem, N.C. "Not only is the active ingredient in Opana ER one of the most extensively studied oral opioids in a clinical development program, its proven dosing every 12 hours can provide durable, lasting relief. Additionally, physicians may need to rotate opioids to effectively manage a patient's chronic pain, maintaining an acceptable balance between pain relief and side-effects."
Endo is revising its guidance for 2006 and currently expects net sales in 2006 to be approximately $880 to $910 million. Combined net sales of Opana ER and Opana are expected to be approximately $20 to $30 million, substantially comprised of Opana ER. Net sales of Lidoderm in 2006 continue to be estimated to be approximately $530 to $540 million. Over the next few weeks, Endo plans to expand its current 370-person sales force by approximately 220 sales representatives to promote all formulations of Opana as well as its existing portfolio of branded products, including Lidoderm and Frova. Additionally, Endo will substantially increase its investment in the Opana franchise and, accordingly, expects to incur a loss for this product franchise in 2006 in connection with this launch. However, the company believes this launch provides another significant growth opportunity to complement its existing portfolio.