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FDA Approves Tuzistra XR

Vernalis and Tris Pharma Receive FDA Approval for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex)

May 1, 2015 — Vernalis plc and Tris Pharma Inc. today announce that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII (DEA Schedule III).

Tuzistra XR is an extended-release oral suspension 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 in adults aged 18 years and older. It is indicated for oral use, with or without food, and is to be dosed every 12 hours.

Tuzistra XR is the only codeine based extended-release oral suspension cough-cold treatment in a U.S. prescription cough cold market which sees 30-35 million prescriptions written each year and is estimated to be worth in excess of $3 billion. Currently available short-acting codeine based cough cold treatments account for approximately 38% of that market. Tuzistra XR has been developed using Tris Pharma Inc.’s LiquiXR™ technology.

Ian Garland, Vernalis’ Chief Executive Officer, commented “The approval of Tuzistra XR is a very significant moment in the evolution of Vernalis to a commercial stage speciality pharmaceutical company. We believe this product offers both patients and physicians an extended relief alternative to existing treatments and presents a significant commercial opportunity for Vernalis. We will be working hard over the coming months to launch Tuzistra XR ahead of the 2015-16 U.S. cough-cold season.”

Ketan Mehta, Chief Executive Officer of Tris, commented “This approval demonstrates the continued success of Tris’ OralXR+ technology and is representative of Tris’ history of developing and manufacturing first-to-market liquid sustained-release products that fill significant unmet patient needs. We are excited our collaboration has advanced patient care in a therapeutic category where most adults seek relief in the form of a liquid.”

About Tuzistra XR

INDICATION

Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII, is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.

Important Limitations of Use: Tuzistra XR is not indicated for pediatric patients under 18 years of age.

IMPORTANT SAFETY INFORMATION

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.

Contraindications

Tuzistra XR is contraindicated:

  • For postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.
  • Patients with known hypersensitivity to codeine, chlorpheniramine or any of the inactive ingredients of Tuzistra XR. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to codeine.

 

Warnings and Precautions

  • Respiratory depression and death have occurred in children who had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the CYP2D6 isoenzyme or high morphine concentrations) and in nursing infants whose mothers were ultra-rapid metabolizers of codeine. Even at labeled doses, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion or shallow breathing). When prescribing codeine-containing drugs, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdosage.
  • Caution should be exercised when Tuzistra XR is administered because of the potential for respiratory depression. If respiratory depression occurs, Tuzistra XR should be discontinued and naloxone hydrochloride should be used, when indicated, and other supportive measures as necessary.
  • Tuzistra XR is a Schedule III controlled prescription product. Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of Tuzistra XR. Tuzistra XR should be prescribed and administered with the same caution appropriate to the use of other opioid drugs.
  • The respiratory depression effects of opioids their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions that may obscure the clinical course of patients with head injuries. The use of Tuzistra XR should be avoided in these patients.
  • Tuzistra XR may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. Patients should be advised to avoid engage in hazardous tasks requiring mental alertness and motor coordination after taking Tuzistra XR. Concurrent use of Tuzistra XR with alcohol or other CNS depressants should be avoided because additional impairment may occur.
  • Tuzistra XR should be used with caution in patients with acute abdominal conditions since the administration of codeine may obscure the diagnosis or clinical course of patients with these conditions. The concurrent use of other anticholinergics with codeine may produce paralytic ileus.
  • Tuzistra XR should be used with caution in elderly or debilitated patients and those with asthma, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression kept in mind.

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, and tremor.

About Vernalis

Vernalis is a revenue generating, commercial stage pharmaceutical company with significant expertise in drug development. The Group has two approved products; Tuzistra™ XR targeting the US prescription cough cold market and, frovatriptan for the acute treatment of migraine. It has an exclusive licensing agreement to develop and commercialise multiple novel products focussed on the US prescription cough cold market as well as eight programmes in its NCE development pipeline. Vernalis has also significant expertise in fragment and structure based drug discovery which it leverages to enter into collaborations with larger pharmaceutical companies. The Company’s technologies, capabilities and products have been endorsed over the last five years by collaborations with leading pharmaceutical companies, including AKP, Biogen Idec, Endo, GSK, Genentech, Lundbeck, Menarini, Novartis, Servier Taisho and Tris.

About Tris Pharma

Tris Pharma is a specialty pharmaceutical company focused on the research and development of technologies-driven products. Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms so patients do not have to swallow a pill. Tris’ Nobuse™ technology provides abuse deterrence for opioids and other abuse-prone drugs. Tris’ R&D and manufacturing facilities are located in Monmouth Junction, New Jersey, U.S.A.

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 commercialisation 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 beneficial terms with suitable partners for the commercialisation and/or development of its products, as well as the achievement of expected synergies from such transactions, the acceptance of 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.

Source: Vernalis plc

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