Vernalis Therapeutics Launches Long-Acting Codeine-Based Cough Suppressant Ahead Of U.S. Cough Cold Season

Tuzistra™ XR (codeine polistirex and chlorpheniramine polistirex) Offers Cough Relief with 12-Hour Dosing

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Sep 08, 2015, 07:00 ET

BERWYN, Pa., Sept. 8, 2015 /PRNewswire/ -- Vernalis Therapeutics Inc., a subsidiary of Vernalis plc (LSE: VER), today announced that Tuzistra™ XR (codeine polistirex and chlorpheniramine polistirex), extended-release oral suspension, CIII (DEA Schedule III) is now available to adult patients and physicians in the United States.

Tuzistra(TM) XR (codeine polistirex and chlorpheniramine polistirex), extended-release oral suspension, CIII is now available to patients and physicians in the U.S.

Tuzistra XR, the only codeine-based cough and cold syrup dosed every 12 hours, was approved by the U.S. Food and Drug Administration on April 30, 2015. It 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. Tuzistra XR was developed using a liquid sustained release technology, LiquiXR™, which enables a 12-hour dosing period.

"The launch of Tuzistra XR marks a significant milestone for Vernalis Therapeutics and demonstrates our capability to build a broad portfolio of unique, long-acting, liquid formulations of branded prescription cough cold products in the U.S. market," said Tom Parker, Senior Vice President of Commercial Operations, Vernalis Therapeutics, Inc. "We are pleased to offer physicians and patients a proprietary Schedule III, 12-hour, codeine and chlorpheniramine combination liquid product to help manage cough and cold symptoms in advance of this year's cough cold season."

"Until now, physicians looking to prescribe a codeine-containing antitussive have been limited to short-acting medications," said Pascal Borderies, MD, SVP Medical Affairs, Vernalis Therapeutics, Inc. "Tuzistra XR's extended-release liquid delivery system allows for less frequent dosing than traditional codeine cough syrups. This makes it a viable option for patients looking to extend the relief of cough and symptoms associated with upper respiratory allergies or the common cold with twice-daily dosing."

For more information about Tuzistra XR visit www.vernalistherapeutics.com.

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 in:

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.
Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been 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. Data are not available for other ethnic groups. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels.
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.
Because of the potential for respiratory depression, caution should be exercised when TUZISTRA XR is administered, 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, TUZISTRA XR should be discontinued and naloxone hydrochloride should be used, when indicated, and other supportive measures as necessary.
Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological 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 and 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 engaging 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.
Chronic use of opioids, including codeine, may result in constipation or obstructive bowel disease especially in patients with underlying intestinal motility disorders. Use with caution in patients with underlying intestinal motility disorders.
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.
Patients should be advised to measure TUZISTRA XR with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, which can result in serious adverse reactions.
TUZISTRA XR should be used with caution in elderly or debilitated patients and those with asthma, persistent or chronic cough, 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.

Please see full Prescribing Information at www.vernalistherapeutics.com.

About the U.S. Cough Cold Market
Each year in the U.S., more than one billion patients visit a physician seeking medical advice, and cough is the most frequent illness-related reason for these visits.¹ On a typical day, a family physician will see at least one patient presenting with cough.²Physicians write 30-35 million prescriptions annually to help patients relieve cough and symptoms associated with upper respiratory allergies or the common cold. Nearly 40 percent of these prescriptions are for short-acting, codeine-based treatment options.³ The U.S. cough cold market is estimated to be worth in excess of $3 billion at current brand pricing.

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 cough, cold and allergy symptoms for extended periods of time. In addition to Tuzistra™ XR, there are four additional 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 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 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.

References

Centers for Disease Control. (2010). National Ambulatory Medical Care Survey: 2010 Summary Tables, Table 9. Twenty leading principal reasons for office visits, by patient's sex: United States, 2010. Available at: http://www.cdc.gov/nchs/data/ahcd/namcs_summary/2010_namcs_web_tables.pdf. Accessed September 1, 2015.
L. Coughlin. Cough: Diagnosis and Management. American Family Physician. 2007 Feb 15;75(4):567-575.
Source: IMS NPA prescription data 12-months to June for each year, Vernalis analysis.