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FDA Approves Vituz

Pernix Therapeutics Receives FDA Approval for Vituz

THE WOODLANDS, Texas--(BUSINESS WIRE)--Feb 28, 2013 - Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company, today announced that its subsidiary, Hawthorn Pharmaceuticals, Inc., has received U.S. Food and Drug Administration (FDA) approval of a new drug application (NDA) for Vituz Oral Solution (hydrocodone bitartrate and chlorpheniramine maleate). Vituz 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.

Cooper Collins, President and CEO of Pernix, said, “Vituz broadens our cough and cold product line and is our first NDA approved by the FDA, since we closed the acquisition of Hawthorn and Cypress at the end of December 2012. We look forward to the launch of this new treatment option for cough and cold symptoms, which is expected prior to the fall of this year.”

Indication for Vituz

Vituz Oral Solution is a combination of hydrocodone bitartrate, an antitussive, and chlorpheniramine maleate, a histamine-1 (H1) receptor antagonist, indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold for adults 18 years of age and older.

Important Safety Information for Vituz

Vituz is contraindicated in patients with known hypersensitivity to hydrocodone bitartrate, chlorpheniramine, or any of the inactive ingredients of Vituz; in patients receiving monoamine oxidase inhibitor (MAOI) therapy or within 14 days of stopping such therapy, and in patients with narrow angle glaucoma, urinary retention, severe hypertension or severe coronary artery disease. The possibility of tolerance and/or dependence, particularly in patients with a history of drug dependence, should be considered. Avoid in patients with head injury, intracranial lesions, or increased intracranial pressure. Exercise caution when using because of the potential for respiratory depression. Patients should be advised to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as Vituz Oral Solution may produce marked drowsiness. Vituz Oral Solution should not be taken with alcohol or other CNS depressants. Use with caution in patients with acute abdominal conditions and in patients with thyroid disease, Addison's disease, prostatic hypertrophy, urethral stricture, or asthma.

The most common adverse reactions of Vituz Oral Solution include: Sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, nausea, psychic dependence, mood changes; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, irritability, and tremor.

About Pernix Therapeutics Holdings, Inc.

Pernix Therapeutics is a specialty pharmaceutical company primarily focused on the sales, marketing, manufacturing and development of branded, generic and OTC pharmaceutical products. The Company manages a portfolio of branded products, including the recently acquired Hawthorn Pharmaceuticals' product line. The Company's branded products for the pediatrics market include CEDAX, an antibiotic for middle ear infections, NATROBA™, a topical treatment for head lice marketed under an exclusive co-promotion agreement with ParaPRO, LLC, and a family of treatments for cough and cold (ZUTRIPRO, BROVEX, ALDEX and PEDIATEX). The Company's branded products for gastroenterology include OMECLAMOX-PAK, a 10-day treatment for H. pylori infection and duodenal ulcer disease, and REZYST™, a probiotic blend to promote dietary management. The Company promotes its branded pediatric and gastroenterology products through its sales force. Pernix markets its generic products through its wholly-owned subsidiaries, Cypress Pharmaceuticals and Macoven Pharmaceuticals. The Company's wholly-owned subsidiary, Great Southern Laboratories, manufactures and packages products for the pharmaceutical industry in a wide range of dosage-forms. A product candidate utilizing cough-related intellectual property is in development for the U.S. OTC market. Founded in 1996, the Company is based in The Woodlands, TX.

Additional information about Pernix is available on the Company's website located at www.pernixtx.com.

Cautionary Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “target” or similar expressions are forward-looking statements. Because these statements reflect the Company's current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. No assurances can be given regarding the Company's future performance. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect the Company's future financial results and could cause actual results to differ materially from those expressed in forward-looking statements. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

 

Contact: Pernix Therapeutics Holdings, Inc.
Joseph T. Schepers, (800) 793-2145 ext. 3002
Director, Investor Relations
jschepers@pernixtx.com

 

 

Posted: February 2013

Vituz (chlorpheniramine and hydrocodone) FDA Approval History

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