Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today announced the introduction of Omeclamox-Pak®, a ten-day therapy of omeprazole delayed-release capsules (20 mg), clarithromycin tablets (500 mg) and amoxicillin capsules (500 mg) 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.
Cooper Collins, President and Chief Executive Officer of Pernix Therapeutics, said, "The introduction of Omeclamox-Pak is an important milestone for Pernix as the company's prescription portfolio continues to broaden with the addition of a new branded product that will be launched by our newly established gastroenterology sales force. We are pleased to offer patients suffering from H. pylori infection and duodenal ulcers with a new treatment option that we expect will be available by prescription in July 2012."
Omeclamox-Pak® is a triple combination medication taken orally to treat Helicobacter pylori infection and eradicate duodenal ulcer disease in adults. Treatment consists of the protein pump inhibitor omeprazole and two broad spectrum antibiotics; clarithromycin tablets and amoxicillin capsules. The medications are to be taken together, twice daily, for ten days.
"We have recruited a new sales force and established a targeted marketing program that will reach gastroenterology professionals in the coming months," said Chuck Hrushka, Vice President of Sales and Marketing at Pernix Therapeutics. "We anticipate physicians and their patients will welcome the short, 10-day dosing regimen, especially when compared to other treatments."
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.
For additional information regarding Omeclamox-Pak, Pernix Therapeutics invites you to visit their exhibitor booth at the Digestive Disease Week annual meeting, held at the San Diego Convention Center; San Diego, California from May 19-22, 2012.
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 Holdings, Inc.
Pernix Therapeutics Holdings, Inc. is a specialty pharmaceutical company primarily focused on the sales, marketing, and development of branded, generic and OTC pharmaceutical products. The Company manages a portfolio 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®) and REZYST IM™, a probiotic blend to promote dietary management. The Company promotes its branded pediatric products through its sales force. Pernix also markets 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.