FDA Approves Cyanocobalamin Nasal Spray for Vitamin B12 Deficiency
Feb 2, 2005 - 11:35:00 AM
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By Akanksha, Pharmacology Correspondent,
[RxPG] Nastech Pharmaceutical Company Inc.("Nastech"),a leader in drug delivery technology, announced the approval by the U.S. Food and Drug Administration (FDA) of Nascobal(R) (Cyanocobalamin, USP) Nasal Spray for the treatment of vitamin B12 (cyanocobalamin) deficiency in patients with pernicious anemia, Crohn's Disease, HIV/AIDS, and multiple sclerosis.
"We are pleased by the rapid FDA approval of Cyanocobalamin Nasal Spray," said Gordon Brandt, M.D., executive vice president,clinical research and medical affairs of Nastech."Importantly, this makes the second FDA approval for Nastech and clearly demonstrates the capabilities and dedication of our regulatory and development teams."
"Due to intestinal inflammation, people with Crohn's disease may have difficulty absorbing vitamin B12," stated Rodger L. DeRose, president and chief executive officer of the Crohn's & Colitis Foundation of America."We hope that this second delivery system will make Cyanocobalamin Nasal Spray an option for more Crohn's disease patients who suffer from vitamin B12 deficiency."
A recent survey of patients with vitamin B12 deficiency sponsored by Questcor and conducted by an independent third party revealed that patients who have used multiple forms of vitamin B12 therapy, including injections, prefer the once weekly at-home intranasal administration of Cyanocobalamin Nasal Spray. Additionally, patients currently receiving injectable cyanocobalamin for their deficiencies are more interested in an intranasal spray formulation than the intranasal gel.
Nastech developed Cyanocobalamin Nasal Spray as an alternative to Cyanocobalamin Gel for Intranasal Administration, an FDA approved product launched in 1997. Worldwide marketing rights to both products were sold to Questcor Pharmaceuticals, Inc. ("Questcor") in June 2003. FDA approval of the product triggers a $2 million milestone payment from Questcor to Nastech. Nastech will manufacture the product line for both Cyanocobalamin Nasal Gel and Cyanocobalamin Nasal Spray under a long-term manufacturing agreement with Questcor.
Cyanocobalamin Nasal Gel has been approved and marketed in the U.S. since 1997 for the treatment of malabsorptive and diet-related vitamin B12 deficiencies and has a proven track record of safety and efficacy. The Cyanocobalamin Nasal Spray new drug application was filed in December, 2003 with the FDA. Many patients do not experience symptoms. For those who do, symptoms of vitamin B12 deficiency can include fatigue, weakness, sore tongue, forgetfulness, weight loss, lack of coordination and difficulty walking. Left untreated, vitamin B12 deficiency may lead to anemia, intestinal problems, and irreversible nerve damage.
As with Cyanocobalamin Nasal Gel, the spray formulation is also indicated for use in patients with pernicious anemia, other malabsorptive conditions that can result in vitamin B12 deficiency such as gastric bypass surgery, Crohn's Disease, HIV/AIDS, and Multiple Sclerosis.
Questcor owns worldwide rights to both Nascobal Nasal Gel and Nascobal Nasal Spray and currently markets the Nascobal Nasal Gel and other products to bariatric surgeons, neurologists, gastroenterologists and select high- prescribing primary care physicians.
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Questcor Pharmaceuticals, Inc.(R) is a specialty pharmaceutical company that acquires, markets and sells brand name prescription drugs for gastrointestinal and neurological use through a U.S. direct sales force and international distributors. Questcor currently markets four products in the U.S.: Nascobal, the only prescription nasal gel formulation of cyanocobalamin (Vitamin B12), that is approved for patients with vitamin B12-deficiency caused by malabsorptive disorders resulting from structural or functional damage, such as bariatric surgery, Crohn's disease and certain neurological conditions; H.P. Acthar(R) Gel (repository corticotropin injection), an injectable drug that is commonly used for certain neurological conditions; Ethamolin(R), (Ethanolamine Oleate) an injectable drug used to treat enlarged weakened blood vessels at the entrance to the stomach that have recently bled, known as esophageal varices; and Glofil-125(R), which is an injectable agent that assesses how well the kidney is working by measuring glomerular filtration rate, or kidney function.
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Additional information about the news article
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Nastech Pharmaceutical Company Inc. is a pharmaceutical company focusing on the development and commercialization of innovative products. These products are based on proprietary molecular biology-based drug delivery technology and are suitable for deliver of both small and large molecule drugs. We and our collaboration partners are developing a diverse portfolio of product candidates for multiple therapeutic areas including obesity, osteoporosis, erectile dysfunction, breakthrough cancer pain and multiple sclerosis. Additional information about Nastech is available at the company's website.
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