THE WOODLANDS, Texas, July 10, 2012 /PRNewswire/ -- Pernix Therapeutics (NYSE: MKT: PTX), a specialty pharmaceutical company, today announced that Omeclamox-Pak® is now available to patients for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori in adult patients. Omeclamox-Pak is a ten-day, triple combination oral therapy comprised of omeprazole delayed-release capsules (20 mg), clarithromycin tablets (500 mg) and amoxicillin capsules (500 mg).
Cooper Collins, President and Chief Executive Officer of Pernix, said, "We are pleased to announce that Omeclamox-Pak is now available by prescription in pharmacies across the country, and physicians and patients will have another therapy option for the treatment of H. pylori and duodenal ulcer disease."
Omeclamox-Pak is the first triple combination medication indicated to eradicate symptoms of H. pylori in just ten days. Current treatment options include dual therapy, consisting of one proton pump inhibitor and only one antibiotic medication, as well as triple combination therapy, prescribed twice daily for 14 days.
Dr. Brian Fennerty, M.D., Professor of Medicine, Division of Gastroenterology at Oregon Health & Science University, said, "Published studies show that a single ten-day regimen of twice-daily therapy with omeprazole, amoxicillin and clarithromycin eradicates 80 percent to 90 percent of H. pylori infections."
Omeprazole is an antisecretory drug, which works by decreasing the amount of acid the stomach produces. Clarithromycin and amoxicillin are antibacterial drugs, which inhibit the growth of bacteria allowing the stomach lining to heal. Omeclamox-Pak is contraindicated in patients with a history of hypersensitivity to omeprazole, any macrolide antibiotic or penicillin. The safety and effectiveness of Omeclamox-Pak in the pediatric population has not yet been established. Omeclamox-Pak was approved by the U.S. Food and Drug Administration in 2011.
Full prescribing information is available at www.Omeclamox.com.
About Helicobacter pylori
H. pylori is a bacterium acquired largely by people living in developing countries. Researchers suspect the bacteria are passed through contact with human saliva and waste, or contaminated food and water. If H. pylori is left untreated, it can damage the stomach and small intestine wall causing peptic ulcer disease, specifically duodenal ulcers. Symptoms of H. pylori-induced duodenal ulcers generally surface in adults and may include burning pain in the abdomen, nausea, vomiting, bloating and weight loss. Nearly two-thirds of the world population is infected with H. pylori, including 50 percent of adults older than age 60 and 20 percent of adults under 40 years old.
About Duodenal Ulcers
Despite common belief, healthcare providers do not attribute the cause of duodenal ulcers to stress, alcohol consumption or spicy foods, though all can further inflame the small intestine wall. Patients with duodenal ulcers caused by H. pylori can be diagnosed through a series of simple tests, including blood, urea breath and stool antigen sampling. Other more invasive procedures can include both an upper gastrointestinal (GI) series and endoscopy. Patients who suffer severe abdominal pains, or blood in stool or vomit, may have ulcers which perforated the duodenal wall.
About Pernix Therapeutics
Pernix Therapeutics is a specialty pharmaceutical company primarily focused on the sales, marketing, and development of branded, generic and OTC pharmaceutical products. The Company manages a port-folio of branded and generic products. 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, a family of prescription treatments for cough and cold (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 subsidiary, Macoven Pharmaceuticals. 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, including the completion of the transaction described above. 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. 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 contained in the Company's Annual Report on Form 10-K. 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.
Joseph T. Schepers, 800-793-2145 ext. 3002
Director, Investor Relations
Karen Dombek, 800-477-9626 ext. 319
MCS Healthcare Public Relations
SOURCE Pernix Therapeutics