NUCYNTA® ER (tapentadol extended-release tablets) Receives FDA Approval for the Management of Moderate to Severe Chronic Pain

Clinical Trial Data Demonstrate Efficacy, Safety and Favorable Tolerability

Raritan, N.J., August 26, 2011 /PRNewswire/ — Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved NUCYNTA® ER, an oral analgesic taken twice daily, for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Although the exact prevalence is unknown, information from the Centers for Disease Control and Prevention and the American Pain Foundation suggests that more than 42 million Americans age 20 and over suffer from chronic pain. Chronic pain is the most common cause of long-term disability, and almost one-third of all Americans will experience severe chronic pain at some point in their lives. Yet despite the treatments available, additional treatment options still are needed to help patients manage their pain appropriately and effectively, according to research published by the American Pain Society.

“In clinical trials, NUCYNTA® ER demonstrated proven efficacy for treating moderate to severe chronic pain,” said Paul Chang, M.D., Vice President, Medical Affairs, Internal Medicine, Janssen Pharmaceuticals, Inc. “We are pleased with the FDA’s decision to approve NUCYNTA® ER as it represents an important new option to help people with chronic pain.”

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Grünenthal GmbH, a privately-owned pharmaceutical company based in Aachen, Germany, conducted the double-blind, randomized, active- and/or placebo-controlled phase 3 studies that evaluated the efficacy and safety of NUCYNTA® ER for the treatment of moderate to severe chronic low back pain and painful diabetic peripheral neuropathy. Additionally, safety also was evaluated in more than 1,100 patients with moderate to severe chronic pain over a one-year period. The findings demonstrate efficacy and safety, a favorable tolerability profile and favorable discontinuation rates.

“Chronic pain is difficult to manage, and even with the treatments available today, it can be a challenge to balance pain relief with a patient’s ability to tolerate the medicine,” said Sunil J. Panchal, M.D., President, National Institute of Pain.* “People with chronic pain will continue to need additional options, so an approval like this is welcome news for this community and the people who suffer from this often debilitating condition.”

To support the appropriate and effective management of chronic pain, Janssen Pharmaceuticals, Inc. believes it is also essential to support educational programs about the safe and responsible use of pain medicines and the prevention of inappropriate use.

Since 2008, the company has supported educational programs that reach a range of audiences, including patients, physicians, caregivers, parents, teens and educators. These include: Prescribe Responsibly (www.PrescribeResponsibly.com) for physicians seeking information on the appropriate prescribing of opioid pain medications; the Let’s Talk Pain Coalition (www.LetsTalkPain.org) to help enhance communication between patients with pain, caregivers and physicians; and Smart Moves, Smart Choices (www.SmartMovesSmartChoices.org) to increase awareness among educators, parents and teens about the serious problem of teen prescription drug abuse in the U.S.

To help ensure the risks of NUCYNTA® ER are communicated accurately, Janssen Pharmaceuticals, Inc. has developed a Risk Evaluation and Mitigation Strategy (REMS) for the medication, in collaboration with the FDA. This REMS, which is similar to those developed for other medicines in this category, educates prescribers about the potential for abuse, misuse, overdose and addiction from exposure to NUCYNTA® ER. To supplement the REMS, the company also utilizes surveillance methodologies to monitor for inappropriate use of its products.

About Tapentadol, NUCYNTA® ER and NUCYNTA®

Tapentadol is a centrally-acting synthetic analgesic. The tapentadol molecule is classified as Schedule II of the Controlled Substances Act.

NUCYNTA® ER (tapentadol extended-release tablets) represents the ongoing commitment of Janssen Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. to bring new and innovative products to patients and physicians for the treatment and management of pain.

NUCYNTA® ER is an oral analgesic indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It is taken twice daily and available in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths.

NUCYNTA® (tapentadol immediate-release tablets) was approved by the FDA on November 20, 2008, for the relief of moderate to severe acute pain in patients 18 years of age or older. It is available in 50 mg, 75 mg, and 100 mg strengths.

Both NUCYNTA® and NUCYNTA® ER are available by prescription only.

Outside the United States, tapentadol is marketed by Janssen Inc. in Canada; Grünenthal GmbH discovered tapentadol and markets immediate- and extended-release formulations of tapentadol (PALEXIA®) in various countries in Europe.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Janssen Pharmaceutical KK, Japan, are developing tapentadol in Japan. In addition, Janssen Pharmaceutical companies have rights to develop and market immediate- and extended-release formulations of tapentadol in select European countries and certain countries in Latin America, the Asia-Pacific region, Africa and the Middle East.

IMPORTANT SAFETY INFORMATION for NUCYNTA® ER (tapentadol extended release)

WARNING: POTENTIAL FOR ABUSE, PROPER PATIENT SELECTION, AND LIMITATIONS OF USE

Potential for Abuse

NUCYNTA® ER contains tapentadol, a mu-opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics.

NUCYNTA® ER can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when prescribing or dispensing NUCYNTA® ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Schedule II opioid substances, which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone, and methadone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

Proper Patient Selection

NUCYNTA® ER is an extended-release formulation of tapentadol indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

NUCYNTA® ER is not intended for use as an as-needed analgesic.

NUCYNTA® ER is not intended for the management of acute or postoperative pain.

NUCYNTA® ER tablets are to be swallowed whole and are not to be split, broken, chewed, dissolved, or crushed. Taking split, broken, chewed, dissolved, or crushed NUCYNTA® ER tablets could lead to rapid release and absorption of a potentially fatal dose of tapentadol.

Patients must not consume alcoholic beverages, or prescription or nonprescription medications containing alcohol. Co-ingestion of alcohol with NUCYNTA® ER may result in a potentially fatal overdose of tapentadol.

CONTRAINDICATIONS

WARNINGS and PRECAUTIONS

ADVERSE REACTIONS

IMPORTANT SAFETY INFORMATION for NUCYNTA® (tapentadol immediate release)

CONTRAINDICATIONS

WARNINGS & PRECAUTIONS

Adverse Events

Please see full Product Information
(http://nucynta.com/sites/default/files/pdf/nucyntaer-pi.pdf)

About Janssen Pharmaceuticals, Inc.

Janssen Pharmaceuticals, Inc. is dedicated to addressing and resolving the major unmet medical needs of our time. Driven by our commitment to patients, healthcare professionals, and caregivers, we strive to develop sustainable and integrated healthcare solutions by working in partnership with all stakeholders on the basis of trust and transparency. Our daily work is guided by meeting goals of excellence in quality, innovation, safety, and efficacy in order to advance patient care.

For more information on Janssen Pharmaceuticals, Inc., visit us at www.janssenpharmaceuticalsinc.com, or follow us on Twitter at www.twitter.com/JanssenUS.

* Dr. Panchal is a paid consultant to Janssen Pharmaceuticals, Inc. However, he was not compensated for his comments to media related to the approval of NUCYNTA® ER.

For more information on NUCYNTA® ER, please contact:

Media:
Jeff Christensen
Tel: (908) 927-3581
Mobile: (908) 938-4828
Jchrist8@its.jnj.com
Bill Foster
Tel: (908) 704-4404
Mobile: (908) 392-6057
wfoster@its.jnj.com

 

Investors:
Louise Mehrotra
Tel: (732) 524-6491
Stan Panasewicz
Tel: (732) 524-2524

 

Videos

"Loading the player…"

MPEG-4 Video

Right-click the button below for ‘SAVE’ options


Related Documents

NUCYNTA ER Fact Sheet
Chronic Pain Fact Sheet
Janssen Pharmaceuticals Fact Sheet


Related Links

nucynta.com/sites/default/files/pdf/nucyntaer-pi.pdf
www.janssenpharmaceuticalsinc.com
www.prescriberesponsibly.com
www.letstalkpain.org
www.smartmovessmartchoices.org