Nuvo Pharmaceuticals® Announces The Canadian Commercial Launch of Suvexx™ - For The Acute Treatment of Migraine
September 9, 2020
- Combination of sumatriptan succinate and naproxen sodium in a single tablet -
MISSISSAUGA, ON, Sept. 9, 2020 /CNW/ - Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX: NRI); (OTCQX: NRIFF), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, today announced that its wholly owned subsidiary, Aralez Pharmaceuticals Canada Inc. (Aralez Canada) has launched Suvexx™ into the approximately $130 million Canadian prescription acute migraine market.
Suvexx (sumatriptan succinate and naproxen sodium tablets) is a fixed-dose combination prescription medication, indicated for the acute treatment of migraine attacks with or without aura in adults. Suvexx helps patients manage acute migraine attacks using a combination of sumatriptan succinate and naproxen sodium in a single tablet. In thirteen phase 3 studies, Suvexx demonstrated early and sustained efficacy superior to sumatriptan and naproxen alone with a safety and tolerability profile similar to sumatriptan and naproxen. Thousands of patients were treated during the development program including patients with menstrual migraine and patients intolerant of other currently approved migraine medications.
"Suvexx was approved by Health Canada in late February of this year and the subsequent launch of Suvexx by our commercial team supports our strategy of building on our existing commercial presence in Canada and expanding our portfolio of migraine treatments. Suvexx adds an additional potential revenue-generating product to our strong product portfolio," said Jesse Ledger, Nuvo's President & Chief Executive Officer. "We have established relationships with neurologists and physicians who treat migraineurs across Canada through our 7 years of promoting Cambia, our first medication used to treat acute migraine."
"Migraine is a neurological disease that impacts close to three million Canadians, the majority of them, women. Migraines are more severe and debilitating than other types of headaches and, consist of moderate to severe throbbing or pulsating pain and are often on one side of the head. Other debilitating symptoms include nausea; vomiting; and hypersensitivity to lights, sounds and smells. Migraine patients suffer with a diminished quality of life and reduced productivity surrounding their migraine attacks. Until recently, physicians have been challenged to find appropriate acute therapies to abort a patient's migraine attack. Our goal is to prescribe medications that provide patients with sustained pain free relief, low recurrence rates of the migraine attack, and with few to no side effects. With the addition of Suvexx to the Canadian market, patients will have a new and innovative option to treat their migraine attacks that is supported by strong clinical data. The introduction of this novel "combination therapy" will be a welcome addition to my clinical practice."
Ian Finkelstein, MD
Director, Toronto Headache & Pain Clinic
"The entry of Suvexx into the Canadian market provides migraine sufferers with an innovative treatment for acute migraine supported by strong clinical data. Suvexx, a combination of sumatriptan succinate and naproxen sodium in a single tablet, provides a novel approach for treating acute migraine. Clinical trials involving thousands of migraineurs demonstrated efficacy and a safety profile that makes me confident in prescribing Suvexx to patients suffering with acute migraine attacks."
Elizabeth Leroux, MD, FRCPC
Headache Neurologist in Montreal and
President of the Canadian Headache Society
"Migraine is a neurological condition which can significantly reduce a sufferers quality of life. Migraineurs experience recurrent debilitating symptoms that affect day-to-day activities, including home life, hobbies, social relationships and work. Many Canadian migraineurs are dissatisfied with their current treatments. Migraineurs and the physicians who care for them welcome the availability in Canada of innovative acute migraine therapies such as Suvexx that increase the likelihood that migraine sufferers can better control their migraines and improve their quality of life."
Dr. Jonathan Gladstone, MD FRCPC
Director, Gladstone Headache Clinic
Consultant Neurologist, Headache Clinic, Hospital for Sick Children
Consultant Neurologist, Cleveland Clinic Canada
Consultant Neurologist, Toronto Raptors
Suvexx is a patent protected, fixed dose combination of naproxen sodium and sumatriptan that was developed by the Aralez Pharmaceuticals Inc. wholly owned subsidiary POZEN, Inc. (POZEN) in collaboration with Glaxo Group Limited, d/b/a GSK (GSK). The product is formulated with POZEN's patented technology (now owned by Aralez Canada) of combining a triptan, sumatriptan 85 mg, with an NSAID, naproxen sodium 500 mg and GSK's RT Technology in a single tablet. In 2008, the U.S. Food and Drug Administration (FDA) approved Treximet (the U.S. brand name for Suvexx) for the acute treatment of migraine attacks, with or without aura, in adults. Treximet is currently commercialized in the U.S. by Currax Holdings USA LLC. Aralez Canada owns the product and intellectual property rights to Suvexx in Canada and Nuvo Pharmaceuticals (Ireland) DAC owns the intellectual property rights to Suvexx outside of Canada.
About Nuvo Pharmaceuticals Inc.
Nuvo (TSX: NRI; OTCQX: NRIFF) is a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products. The Company targets several therapeutic areas, including pain, allergy and dermatology. The Company's strategy is to in-license and acquire growth-oriented, complementary products for Canadian and international markets. Nuvo's head office is located in Mississauga, Ontario, Canada, the international operations are located in Dublin, Ireland and the Company's manufacturing facility is located in Varennes, Québec, Canada. The Varennes facility operates in a Good Manufacturing Practices (GMP) environment respecting the U.S, Canada and E.U. GMP regulations and is regularly inspected by Health Canada and the U.S. Food and Drug Administration. For additional information, please visit www.nuvopharmaceuticals.com.
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SOURCE Nuvo Pharmaceuticals Inc.
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