BERWYN, Pa., Oct. 11, 2016
BERWYN, Pa., Oct. 11, 2016 /PRNewswire/ -- Vernalis Therapeutics, Inc. today announced that it has begun promoting MOXATAG® (amoxicillin extended-release) Tablets to primary care physicians in the U.S. MOXATAG is the first and only approved once-daily formulation of the widely-used antibiotic amoxicillin. Parent company, Vernalis plc (LSE: VER), acquired the U.S. rights to MOXATAG from Pragma Pharmaceuticals, LLC in 2015.
Approved by the FDA in 2008, MOXATAG is a penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 years of age or older.
"We are excited to be promoting MOXATAG, the only once-daily formulation of the well-known antibiotic amoxicillin to physicians in the U.S. The benefit of taking one pill per day versus multiple times a day may represent an improvement in convenience for patients," said Sandy Sommer, President and Chief Operating Officer, Vernalis Therapeutics, Inc. "MOXATAG is a natural complement to our 12-hour codeine based prescription medication, TUZISTRA® XR, as both products offer physicians and patients an extended-release alternative to existing treatments."
The NDC number for Vernalis-labeled MOXATAG (amoxicillin extended-release) Tablets in 30-count bottles is 69442-0030-01. The NDC number for 10-count bottles is 69442-0030-10. For questions about ordering MOXATAG, please call Vernalis at 1-88VERNALIS (1-888-376-2547).
The U.S. Antibiotic Market
According to IMS Health, (MAT February 2015 data) 14 million patients diagnosed with tonsillitis and/or pharyngitis secondary to S. pyogenes were treated with antibiotics, and of these patients, three million people 12 years of age and older were treated with amoxicillin. The target market is estimated to be between two and three million prescriptions annually for patients 12 years of age or older that are treated by primary care physicians.
MOXATAG (amoxicillin extended-release) is a penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 years and older.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of MOXATAG and other antibacterial drugs, MOXATAG should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Dosage and Administration
The recommended dose of MOXATAG for tonsillitis and/or pharyngitis is 775 mg once daily taken within 1 hour of finishing a meal for 10 days. The full 10-day course of therapy should be completed for effective treatment of tonsillitis and/or pharyngitis secondary to S. pyogenes. Do not chew or crush tablet.
The technology behind once-daily dosing
Through its delivery system, MOXATAG releases medicine in 3 separate pulses over time in different parts of the intestinal tract. This timed release of medicine throughout the day ensures that there is enough amoxicillin in your system to treat your infection with 1 dose each day for 10 days.
IMPORTANT SAFETY INFORMATION:
TUZISTRA® XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII
WARNING: DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE
Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism
INDICATIONS AND USAGE
TUZISTRA XR is a combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1 (H1) receptor antagonist indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold.
Limitation of Use: Not indicated for pediatric patients under 18 years of age.
IMPORTANT SAFETY INFORMATION
About Vernalis Therapeutics, Inc.
Vernalis Therapeutics, Inc., commercializes prescription pharmaceutical products in the U.S. on behalf of its parent organization, Vernalis plc (LSE: VER). The Company is currently focused on marketing and distributing prescription products that are uniquely engineered to relieve respiratory symptoms for extended periods of time. In addition to MOXATAG and TUZISTRA XR, the Company has four extended-release cough cold products in active development. For more information, visit www.vernalistherapeutics.com.
Vernalis Forward-Looking Statement
This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events including the clinical development and regulatory clearance of the Company's products, the Company's ability to find partners for the development and commercialization of its products, as well as the Company's future capital raising activities. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the ability of the Company to identify and agree to beneficial terms with suitable partners for the commercialization and/or development of its products, as well as the achievement of expected synergies from such transactions, the acceptance of TUZISTRA XR, MOXATAG, frovatriptan and other products by consumers and medical professionals, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.
© 2016 Vernalis Therapeutics, Inc. All rights reserved.
MOXATAG and TUZISTRA are licensed trademarks of Vernalis Therapeutics, Inc.
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SOURCE Vernalis Therapeutics, Inc.PR Newswire
Last updated on: 11/10/2016
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