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Press Release

Vernalis Begins Promotion Of MOXATAG® (Amoxicillin Extended-Release) Tablets To Primary Care Physicians In The US

Vernalis Therapeutics,Inc.
Posted on: 11 Oct 16

PR Newswire

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."

Product Information
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.

Indication

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:

  • Contraindications: Patients with known serious hypersensitivity to amoxicillin or to other drugs in the same class or patients who have demonstrated anaphylactic reactions to beta-lactams
  • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy and are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens, so careful inquiry about a history of hypersensitivity reactions to penicillins, cephalosporins or other allergens should be made. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.
  • Clostridium difficile associated diarrhea (ranging from mild diarrhea to fatal colitis) has been reported with nearly all antibacterial agents, including amoxicillin. Evaluate if diarrhea occurs.
  • The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted.
  • Mononucleosis rash: Ampicillin-class antibiotics should not be administered to patients with mononucleosis because a high percentage develops a rash.
  • Risk of development of drug-resistant bacteria is increased by prescribing amoxicillin in the absence of proven or strongly suspected bacterial infection or treating prophylactically and is unlikely to provide benefit to the patient.
  • False-positive urinary glucose tests may occur with amoxicillin. Glucose tests based on enzymatic glucose oxidase reactions (such as Clinistixâ) are recommended.
  • The most common drug-related adverse reactions (incidence ≥1.0 %) are vulvovaginal mycotic infection, diarrhea, nausea, vomiting and headache.

To report SUSPECTED ADVERSE REACTIONS, contact Vernalis Therapeutics, Inc. at 1-855-705-9546 and www.vernalistherapeutics.com  or FDA at 1-800 -FDA-1088 or www.fda.gov/medwatch.    

  • Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.
  • Reduced efficacy of combined oral estrogen/progesterone contraceptives may result from use of amoxicillin or other antibiotics.
  • Pediatrics: The safety and effectiveness of MOXATAG in pediatric patients younger than 12 years has not been established.
  • Renal Impairment: MOXATAG has not been studied in patients with renal impairment; however a reduction of amoxicillin dose is generally recommended for patients with severe renal impairment. Therefore, MOXATAG is not recommended for use in patients with severe renal impairment (CrCl < 30 mL/min) or patients on hemodialysis.

Click here for full Prescribing 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

  • CONTRAINDICATIONS
    • Postoperative pain management of children undergoing tonsillectomy and/or adenoidectomy.
    • Patients with known hypersensitivity to codeine, chlorpheniramine, or any of the product components of TUZISTRA XR.
  • WARNINGS AND PRECAUTIONS
    • Risk of death in ultra-rapid metabolizers: Conversion of codeine into its active metabolite, morphine, may occur more rapidly and completely resulting in higher than expected morphine levels and respiratory depression or death. Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype, which prevalence varies widely, and is estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs.
    • Dose-related respiratory depression: Use with caution, including when used postoperatively, in patients with pulmonary disease or shortness of breath, or whenever ventilator function is depressed.  Overdose of codeine in adults has been associated with fatal respiratory depression, and the use of codeine in children has been associated with fatal respiratory depression.  If respiratory depression occurs, discontinue the drug and use naloxone or other supportive measures as necessary.
    • Drug dependence: Prescribe with caution that is appropriate to the use of other opioids.
    • Head injury and increased intracranial pressure:  Avoid in patients with head injury, intra-cranial lesions, or increased intracranial pressure.
    • Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating heavy machinery. Avoid concurrent use of alcohol or other central nervous system depressants.
    • Obstructive Bowel Disease Caution: Chronic use may result in constipation or chronic obstructive bowel disease, especially in patients with underlying intestinal motility disorders.
    • Acute abdominal conditions: Use with caution in patients with acute abdominal conditions.
    • Dosing Caution: Measure dose with an accurate milliliter measuring device; a household teaspoon is not accurate and could lead to overdosage, resulting in serious adverse reactions.
    • Special risk patients: Caution in elderly patients and those with asthma, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture.
  • ADVERSE REACTIONS:
    • Common adverse reactions of TUZISTRA XR include: nausea and vomiting, constipation, abdominal distension, abdominal pain, blurred vision, diplopia, visual disturbances, confusion, dizziness, depression, drowsiness, sedation, headache, euphoria, facial dyskinesia, feeling faint, light-headedness, general feeling of discomfort or illness, excitability, nervousness, agitation, restlessness, somnolence, insomnia, dyskinesia, irritability, tremor.

To report SUSPECTED ADVERSE REACTIONS, contact Vernalis Therapeutics, Inc. at 1-855-705-9546 and www.vernalistherapeutics.comor FDA at 1-800 -FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing 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.
VTI-0024 09/2016

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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/vernalis-begins-promotion-of-moxatag-amoxicillin-extended-release-tablets-to-primary-care-physicians-in-the-us-300342635.html

SOURCE Vernalis Therapeutics, Inc.

PR Newswire
www.prnewswire.com

Last updated on: 11/10/2016

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