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Pernix Therapeutics Receives FDA Approvals

Pernix Therapeutics Holdings (NASDAQ: PTX), 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.

The Company today also announced that its subsidiary, Cypress Pharmaceuticals, Inc., was granted final approval by the FDA for an abbreviated new drug application (ANDA) for Mefenamic Acid Capsules USP, 250 mg. This product is the generic version of Ponstel Capsules, 250 mg, and is indicated for relief of mild-to-moderate pain in patients 14 years of age and older and the treatment of primary dysmenorrhea.

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.”

Mr. Collins continued, “We are also pleased to receive regulatory approval from the FDA for Mefenamic Acid Capsules, a generic version of Ponstel capsules. We expect to launch this product in the second quarter of 2013.”

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.

Indication for Mefenamic Acid Capsules Mefenamic acid capsules are indicated for relief of mild to moderate pain in patients 14 years of age and older, when therapy will not exceed one week (7 days). The product is also indicated for treatment of primary dysmenorrhea.

Important Safety Information for Mefenamic Acid Capsules Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.

Mefenamic acid capsules, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up.

Mefenamic acid capsules, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulceration and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up.

Mefenamic acid capsules, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.

Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.

Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu like” symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.

Patients should be informed of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling in the face or throat). If these occur, patients should be instructed to seek immediate emergency help.

In late pregnancy, as with other NSAIDs, mefenamic acid should be avoided because it may cause premature closure of the ductus arteriosus.

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.

Posted-In: News FDA

 

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