J&J Wins Nucynta ER Approval, Targets Chronic Pain Market

The company plans a push for the extended release formulation of its opioid medication.

Johnson & Johnson has garnered approval for an extended release formulation of its opioid pain medication Nucynta (tapentadol) for the treatment of moderate to severe chronic pain.

Despite slow sales of the immediate release version, the company believes there is a significant market for this new medication. The company announced the approval Aug. 26.

"It's really like comparing apples to oranges when trying to compare the immediate release formulation to the extended release Nucynta. They are just completely different markets," said J&J representative Jeff Christensen in an interview.

The immediate release version of the drug was approved in November 2008 for the treatment of moderate to severe acute pain and has failed to ever take off as a commercial success for the company. J&J does not break out the sales of the drug because they are not significant enough.

"In the two years since the product was approved by FDA, health care professionals have written more than half a million prescriptions for Nucynta, as documented in the IMS National Prescription Audit," the firm said in a statement to "The Pink Sheet" in early 2011.

Yet, J&J believes that the extended release formulation will play a different role now that it has been approved for chronic patients.

"We will be able to provide doctors with options now for treating different kinds of pain," said Paul Chang, VP of internal medicine and medical affairs at Janssen Pharmaceuticals, a division of J&J.

Chronic pain is typically seen as recurring pain or pain that lasts several months - like back pain, while acute pain lasts only a few days - much like a toothache. Sales of the top three categories for chronic pain in the U.S. (codeine and combinations, morphine and opium derivatives, and Lyrica [Pfizer's pregabalin]) came to approximately $10 billion in 2010 (Also see "Medimmune Bets on Pain: Why The Large Molecule Specialist Thinks It Can Win" - Pink Sheet, 27 Jun, 2011.). Chang said that the unique dual mechanism of Nucynta and its favorable tolerability profile could differentiate it in the crowded pain market.

Tapentadol has a unique mechanism; acting as an oral analgesic that binds to the mu-opioid receptors (like other opioid treatments), but also inhibiting norepinephrine reuptake - making it stand out amongst other opioid treatments.

Not Your Class-Wide REMS

FDA approved Nucynta ER with a Risk Evaluation and Mitigation Strategy, but not the class-wide REMS that sponsors were to submit for all long-acting/extended release opioid products by Aug. 17 (Also see "Opioid Class-Wide REMS May Launch Without Element To Monitor Prescribing" - Pink Sheet, 8 Aug, 2011.).

The current Nucynta REMS is an interim measure until FDA approves the class-wide version, which includes manufacturer-funded physician education efforts (Also see "FDA's CME Expectations For Opioid Prescribers Keep Sponsors At A Distance" - Pink Sheet, 8 Aug, 2011.).

J&J already has plans in the works to educate both doctors and consumers about the proper use of opioids. The Big Pharma has been adding content to www.PrescribeResponsibly.com and to www.LetsTalkPain.com to help its target audience better understand how the drug should be used. "While we have offered therapies for pain management for many years, we think it is extremely important to provide education around the use of these products," said Chang.

Several companies, including Pfizer Inc., also have been trying to develop abuse-resistant or tamper-deterrent pain medications to address abuse, but have failed to garner enough evidence for these claims to be included in the label. J&J now stands in the same position. While J&J claims that Nucynta ER was "designed to provide a high degree of mechanical resistance" that would make it less prone to crushing or chewing for misuse, the company recognizes that it does not have enough clinical evidence to seek a tamper-deterrent claim for the ER label.

The New Drug Application for Nucynta ER was submitted in December 2009 (Also see "Pain Market Draws New NDA Submissions" - Pink Sheet, 3 Dec, 2009.), but received a "complete response" from FDA in October 2010 asking for further clarification of the mechanical resistance formulation. The drug is sold in Europe by its creator, privately-held German company Grunenthal GMBH (Also see "Private Grünenthal Aims For Leadership In Pain" - Pink Sheet, 21 Feb, 2011.), which licensed the U.S. rights for tapentadol to J&J in 2003.

-Lisa LaMotta ([email protected])