Averitas Pharma Commercializes Qutenza® in the US

Wednesday, November 14, 2018 Drug News
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MORRISTOWN, New Jersey, November 14, 2018 /PRNewswire/ --

Averitas Pharma, a recently acquired Grünenthal Group company,

announced that it has taken over the US commercialization of Qutenza® (capsaicin) 8% patch on October 30, after the acquisition of the product by Grünenthal on the same day. Qutenza® is approved in the US for
the management of neuropathic pain associated with postherpetic neuralgia. A single, 1-hour, localized treatment with Qutenza® may provide 3 months of relief from post-shingles nerve pain.

"We're happy to establish Grünenthal's commercial footprint in the largest pharma market in the world," says Douglas Stefanelli, President of Averitas Pharma. "With Qutenza®, we have an exciting opportunity in front of us. There's still a high unmet medical need in pain management, especially for non-opioid treatments. Our plans include changing the commercial distribution model for Qutenza® to provide patients and health care providers with improved access to the product."

To support the Qutenza® commercialization, Averitas Pharma expects to add new positions in New Jersey and across the country.

"As a leader in pain research and management, we're dedicated to bringing solutions for patients with high unmet medical needs. Qutenza® has a broad neuropathic pain label in Europe and Averitas Pharma is actively pursuing the regulatory approvals necessary to support expanding the US label," adds Mark Fladrich, Grünenthal's Chief Commercial Officer.  

About Averitas Pharma - Averitas Pharma aims to be more than just another pharmaceutical company. We focus on bringing non-opioid pain relief products to market, keeping treatment prices reasonable, and making the use of our products efficient for both patients and physicians. We are located in Morristown, NJ.

About Grünenthal - Grünenthal is an entrepreneurial, science-based pharmaceutical company specialized in pain, gout and inflammation. Our ambition is to deliver four to five new products to patients in diseases with high unmet medical need by 2022 and become a € 2 bn company. We are a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients. By sustainably investing in our R&D above the industrial average, we are strongly committed to innovation.

Grünenthal is an independent, family-owned company headquartered in Aachen, Germany. We are present in approx. 30 countries with affiliates in Europe, Latin America and the US. Our products are sold in more than 100 countries with approximately 5,200 employees worldwide. In 2017, Grünenthal achieved revenues of approx. € 1.3 bn.

More information: www.grunenthal.com

About Qutenza® 

Qutenza® is indicated for the management of neuropathic pain associated with postherpetic neuralgia.

IMPORTANT SAFETY INFORMATION 

Treatment with Qutenza® must be performed only by a healthcare provider. You should never apply or remove Qutenza® yourself.

Warnings and Precautions:

  • Qutenza® is not for use near eyes or mucous membranes. Do not sniff or inhale near the Qutenza® patch as this may cause you to cough or sneeze
  • Do not touch the Qutenza® patch with your hands. If you touch the patch, it may cause burning and stinging; if this occurs, tell your healthcare provider
  • Even though a numbing medicine is used on the skin before applying Qutenza®, some patients may still experience substantial pain during the treatment. Tell your healthcare provider if you are experiencing pain; a cool compress or medicine for the pain can be provided to help lessen your discomfort
  • Qutenza® can cause serious side effects including pain and increases in blood pressure during or right after treatment
  • Your healthcare provider should check your blood pressure during treatment with Qutenza®
  • Patients who have high blood pressure that is not well controlled by medicine, or who have had recent heart problems, stroke, or other vascular problems, may be at increased risk and should discuss with their doctor whether Qutenza® is right for them
  • If opioids are used to treat pain associated with the application procedure, please note that opioid treatment may affect the patient's ability to perform potentially hazardous activities such as driving or operating heavy machinery

Side Effects:

  • In clinical studies, the most common drug-related side effects of Qutenza®, which occurred in 5% or more of patients, included redness, pain, itching, or small bumps where Qutenza® was applied, and nausea
  • You should tell your doctor if any side effects bother you or do not go away

These are not all the side effects of Qutenza®. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088. For more information, ask your healthcare provider or pharmacist.

For the full Prescribing Information, please visit www.Qutenza.com

Qutenza® is a registered US trademark of Averitas Pharma, Inc.

72512-QZ-10

For further information, please contact:  Douglas Stefanelli, President Averitas Pharma, Inc. Phone: +1-908-745-2271 dstefanelli@averitaspharma.com Averitas Pharma, Inc. 360 Mt. Kemble Avenue, Morristown, NJ 07960

SOURCE Averitas Pharma



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