FDA Approves Mission Pharmacal Company's Plan to Sell Osteoporosis Drug
Published: Oct 12, 2012
SAN ANTONIO, Oct. 11, 2012 /PRNewswire/ -- Mission Pharmacal Company today announced that BINOSTO(alendronate sodium) Effervescent Tablet for buffered oral solution (70 mg) is now available by prescription in the United States. The U.S. Food and Drug Administration has approved BINOSTO to treat osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis.
BINOSTO delivers easy-to-swallow osteoporosis treatment and fracture prevention at the hip and spine -- alendronate sodium -- in a once weekly, buffered solution. BINOSTO represents a true innovation in the delivery of osteoporosis and bone fracture prevention medication, especially for those patients who prefer not to swallow tablets, suffer with dysphagia, or have other medical difficulties swallowing pills.
"We are very pleased to add BINOSTO to our line of bone health products," says Terry Herring, President of Commercial Operations at Mission Pharmacal. "With this exciting new treatment option, physicians can rest easily, knowing they are prescribing an easy-to-take and proven therapy for their osteoporosis patients that protects against fracture risk at the hip and spine."
Although osteoporosis is often thought of as a disease which impacts mostly women, it affects men as well. While women do suffer relatively rapid bone loss in the first few years after menopause, it should be noted that by about age 65, men and women lose bone mass at the same rate.i
With one of every two postmenopausal women at risk for an osteoporosis fracture, osteoporosis affects more than 200 million women and men worldwide and more than 10 million people in the United States, yet the gravity of the disease is often underestimated. According to an article published in the December 6, 2011, issue of the Annals of Internal Medicine, a woman's lifetime risk of dying from hip fracture is similar to her risk of dying from breast cancer.ii
"Osteoporosis is widespread, with serious consequences for patients, including mortality which is often seen after suffering a hip fracture. In fact, up to 24 percent of patients with a hip fracture end up dying from complications within 12 months. And, unfortunately, many people incorrectly consider osteoporosis to be a normal part of aging. That's because it is largely asymptomatic,"iii said Sol Epstein, MD, professor of medicine and geriatrics at Mount Sinai School of Medicine in New York. "But osteoporosis is treatable. With the many new treatment options available, there is no reason for women to suffer the loss of independence and the pain and even mortality associated with osteoporotic fractures."
For anyone with osteoporosis, the best protection against suffering from a fracture is taking medications as prescribed by an authorized healthcare provider. However, studies show that people who have trouble swallowing pills are much more likely to stop taking their medication. Taken just once a week, strawberry flavored BINOSTO is a buffered effervescent solution that can help patients with swallowing difficulties be more compliant and decrease the risks of disabling fractures.
BINOSTOis a once weekly, strawberry flavored effervescent tablet containing alendronate (70mg) that rapidly dissolves in half a glass (4 oz.) of plain room temperature water to make a buffered solution. BINOSTO is available in packs of four. The national drug code number is 0178-0101-02.
BINOSTO was developed by EffRx based on an agreement with Merck & Co, Inc. granting EffRx the worldwide rights to all effervescent and related patents of FOSAMAX® (alendronate). Patents have been granted to EffRx providing exclusivity for BINOSTOthrough February 2023. Additional patents are pending.
About Mission Pharmacal Company
Mission Pharmacal is a privately held pharmaceutical company based in San Antonio, Texas. For more than 65 years, the company has been committed to meeting the unique healthcare needs of women throughout all stages of life, pediatric patients, and those persons dealing with urologic and dermatologic conditions. The company has a proven track record of identifying unmet healthcare needs and developing both innovative prescription and over-the-counter products to meet these needs. Using only the purest ingredients, Mission Pharmacal provides physicians and consumers with the highest quality pharmaceutical and dietary supplement products on the market today. Mission Pharmacal is a proud national supporter of the March of Dimes Foundation, whose mission is to improve the health of babies by preventing birth defects, premature birth, and infant mortality. For more information about the company, visit www.missionpharmacal.com.
EffRx Pharmaceuticals SA is a drug delivery company based in Freienbach, Switzerland. EffRx specializes in improving existing high volume pharmaceutical products by utilizing its novel techniques in different effervescent executions. The primary focus of EffRx is in metabolic bone disease, oncology supportive care, pediatric medications, and support to larger companies in Life Cycle Management. For more information about the company, visit www.effrx.com.
SOURCE Mission Pharmacal