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FDA Approves NUCYNTA® ER (tapentadol) Extended-Release Oral Tablets for the Management of Neuropathic Pain Associated with Diabetic
Peripheral Neuropathy

Clinical Trial Data Demonstrate Efficacy and Safety for First Opioid Indicated for Patients with Painful Diabetic Peripheral Neuropathy

Raritan, N.J., August 29, 2012 /PRNewswire/ — Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for NUCYNTA® ER (tapentadol) extended-release tablets, an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

NUCYNTA® ER is the first and only opioid approved by the FDA for neuropathic pain associated with DPN. In addition to this new indication, NUCYNTA® ER is currently approved 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.

Diabetes affects nearly 26 million people in the United States, and approximately 60 to 70 percent of people with diabetes have some form of neuropathy. The most common type of neuropathy is DPN, which causes pain or loss of feeling in the toes, feet, legs, hands and arms; it may also include a persistent burning, tingling or prickling sensation. It is estimated that DPN affects nearly eight million people in the United States. Because the complex pathophysiology of DPN involves both central and peripheral mechanisms, certain patients with DPN may require treatment with multiple agents.

“Pain from DPN can be difficult to manage, leaving some patients and healthcare professionals looking for alternative treatments,” said Keith A. Candiotti, M.D., Professor of Anesthesiology and Internal Medicine, University of Miami School of Medicine.* “NUCYNTA® ER is a different option than currently approved medications for the management of painful DPN and may be an important new choice for these patients.”

NUCYNTA® ER is a centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that NUCYNTA® ER acts as both a mu-opioid receptor and a norepinephrine reuptake inhibitor.

Data from two randomized-withdrawal, placebo-controlled Phase 3 trials showed, among patients who had at least a one-point reduction in pain intensity during three weeks of treatment with NUCYNTA® ER, those who continued on the same dose of NUCYNTA® ER that was titrated to balance individual tolerability and efficacy (100-250mg twice daily) for an additional 12 weeks experienced significantly better pain control compared to those who switched to placebo. The findings also demonstrated that NUCYNTA® ER was generally well tolerated. The most common (≥10% of NUCYNTA® ER treated patients) adverse reactions were nausea, constipation, vomiting, dizziness, headache and somnolence.

“The approval of NUCYNTA® ER for DPN pain represents the ongoing commitment of Janssen to bring new and innovative products to patients and physicians for the management of pain,” said Paul Chang, Vice President, Medical Affairs, Janssen Pharmaceuticals, Inc. “It is exciting that our in-depth experience in pain management allows us to continue to provide patients with effective options to treat their pain.”

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

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, 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 United States.

About Tapentadol and NUCYNTA® ER

Tapentadol is a centrally-acting synthetic analgesic. The tapentadol molecule is classified as Schedule II of the Controlled Substances Act. NUCYNTA® ER was approved by the FDA in August 2011. It is an oral analgesic available by prescription only for the following indications: the management of moderate to severe chronic pain in adults and the management of neuropathic pain associated with DPN in adults, when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. NUCYNTA® ER is taken twice daily and available in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths.

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 several countries worldwide.

Janssen Research & Development, LLC 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 Oral Tablets

WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL

Abuse Potential
NUCYNTA® ER contains tapentadol, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient’s risk for opioid abuse or addiction prior to prescribing NUCYNTA® ER. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depressive disorder). Routinely monitor all patients receiving NUCYNTA® ER for signs of misuse, abuse, and addiction during treatment.

Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of NUCYNTA® ER, even when the drug has been used as recommended and not misused or abused. Proper dosing and titration are essential, and NUCYNTA® ER should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of NUCYNTA® ER or following a dose increase. Instruct patients to swallow NUCYNTA® ER tablets whole. Crushing, dissolving, or chewing NUCYNTA® ER can cause rapid release and absorption of a potentially fatal dose of tapentadol.

Accidental Exposure
Accidental ingestion of NUCYNTA® ER, especially in children, can result in a fatal overdose of tapentadol.

Interaction With Alcohol
The co-ingestion of alcohol with NUCYNTA® ER may result in an increase of plasma levels and potentially fatal overdose of tapentadol. Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol while on NUCYNTA® ER.

CONTRAINDICATIONS

WARNINGS and PRECAUTIONS

ADVERSE REACTIONS IN CLINICAL STUDIES

For full prescribing information for NUCYNTA® ER, including boxed warnings, please click here.

About Janssen Pharmaceuticals, Inc. and Janssen Research & Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop and bring innovative products, services and solutions to people throughout the world.

Janssen Pharmaceuticals, Inc. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas. Innovative therapies Janssen Pharmaceuticals, Inc. offers include ACIPHEX® (rabeprazole sodium), DORIBAX® (doripenem for injection), ELMIRON® (pentosan polysulfate sodium), NUCYNTA® (tapentadol), NUCYNTA® ER (tapentadol) extended-release tablets and XARELTO® (rivaroxaban) tablets. The full prescribing information for NUCYNTA® ER, including boxed warnings, is available here; the full prescribing information for XARELTO®, including boxed warnings, is available here.

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

* Dr. Candiotti has been a paid consultant to Janssen Pharmaceuticals, Inc. However, he was not compensated for his comments to media relating to the approval of NUCYNTA® ER.

# # #

Media contact:

William Foster
Phone: 908.704.4404
Mobile: 908.392.6057
wfoster@its.jnj.com

Investor contact:

Stan Panasewicz
Phone: 732.524.2524

 

Video

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NUCYNTA® ER (tapentadol) Extended-Release oral tablets, various doses
NUCYNTA® ER (tapentadol) Extended-Release oral tablets, various doses
NUCYNTA® ER (tapentadol) Extended-Release oral tablets, various doses
NUCYNTA® ER (tapentadol) Extended-Release oral tablets, various doses

Related Documents

NUCYNTA® ER Product Fact Sheet
Diabetic Peripheral Neuropathy Infographic
Biography for Keith Candiotti, M.D.

Related Links

www.nucynta.com
www.janssenpharmaceuticalsinc.com
www.janssenrnd.com

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