Brand Name: Pletal Active Ingredient: cilostazol Approved uses: the reduction of symptoms of intermittent claudication, as indicated by an increase in walking distance Dosage Form(s): Tablets (50 mg and 100 mg) Company Name: Otsuka America Pharmaceutical, Inc. Treatment options for intermittent claudication – a severe pain, aching or cramping in the legs that occurs with walking – include exercise regimens, surgery, and pharmacological therapy. Until recently the only medication available for the treatment of intermittent claudication has been Trental(R) (pentoxifylline).
Immunex submitted an NDA – New Drug Application – for Novantrone (mitoxantrone) on June 7, 1999 for a new multiple sclerosis (MS) indication, and it was granted “priority review” status on July 17, 1999. Novantrone was initially indicated for the treatment of patients with pain due to advanced hormone-refractory prostate cancer. It can also be used as a component of combination therapy for acute nonlymphocytic leukemia in adults.
Brand Name: Sonata Active Ingredient: zaleplon Indication: Treatment of short-term insomnia Company Name: Wyeth-Ayerst Laboratories, Inc. According to the National Sleep Foundation, insomnia affects nearly 83 million Americans; however, many people avoid sleep aids for fear of next-day drowsiness.
Some 4 million Americans are afflicted with Alzheimer’s disease, a number that is expected to grow as the population ages. Tacrine (Cognex) and donepezil (Aricept) are prescription drugs currently available to treat symptoms or slow progression of the disease.
Brand Name: Malarone Active Ingredient: atovaquone and proguanil hydrochloride Indication: Treatment and prevention of P. falciparum malarial infection in adults and children Company Name: Glaxo Wellcome Inc. The antimalarial drug atovaquone was developed in the 1980s and was shown to be effective when used alone, but a recurrence of malaria was observed in some patients over time.
Brand Name Drug: Actonel Active Ingredient Drug: risedronate sodium Indication: Treatment and prevention of postmenopausal osteoporosis and glucocorticoid-induced osteoporosis (also approved for Paget’s disease of the bone in March 1998). Actonel (risedronate disodium) was approved in 1998 for the treatment of Paget’s disease. Now the drug, manufactured by Procter & Gamble and co-marketed with Aventis Pharmaceuticals, has received approval from the FDA (in April 2000) for the treatment and prevention of postmenopausal osteoporosis (PMO) and glucocorticoid-induced osteoporosis (GIO).
Brand Name: Tamiflu Active Ingredient: oseltamivir phosphate Indication: Treatment of influenza A and B Company Name: Hoffmann-La Roche Inc. and Gilead Sciences, Inc. Some 40 million Americans develop the flu every year, putting about 300,000 in the hospital.
Osteoporosis affects over 10 million Americans, and it is estimated that an additional 15 to 20 million people are at risk for developing the disease. The majority (80%) of those afflicted with osteoporosis are female. The onset of osteoporosis occurs as early as age 40 and it is responsible for bone fractures in nearly half of all women over age 50.
In 1998, Pharmacia & Upjohn’s Camptosar (irinotecan hydrochloride injection, or CPT-11) was approved by the FDA for the treatment of metastatic colorectal cancer in patients whose disease has recurred or progressed following treatment with 5-fluorouracil (5FU). The drug was hailed by cancer specialists because it was the first new chemotherapy drug approved for colorectal cancer in more than 40 years.
Schizophrenia afflicts some one percent of the world’s population and requires lifelong treatment. In the US alone, the illness costs the country more than $104 billion in hospital costs, medications, health-care services, and lost productivity.
Ansaid (flurbiprofen) is indicated for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. Ansaid is also indicated for the relief of pain associated with dysmenorrhoea.
Plan B (levonorgestrel), a progestin-only emergency contraceptive regimen, is the first drug specifically designed as emergency contraceptive to receive FDA approval. The only other approved emergency contraception regimen is Preven. Preven, marketed by Gynetics, follows the Yuzpe regimen, which contains two 0.25 mg levonorgestrel tablets and one 0.05 mg ethinyl estradiol tablet.
Another new antiseizure medication has entered to drug arena, the latest in a spate of new drugs for partial onset epilepsy (see previous articles on Keppra and Trileptal). On March 28, 2000, the FDA approved Zonegran (zonisamide) as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
Following a priority review, Zaditor (ketotifen) was approved by the FDA on July 2, 1999. The priority review was granted because, as an antihistamine for ocular itching, Zaditor is in a different class from other currently approved ocular itching drugs.
Agenerase (amprenavir) – the first new protease inhibitor in two years – is the fifth protease inhibitor to reach the US market. Agenerase, developed by Vertex Pharmaceuticals, Inc. and licensed to Glaxo Wellcome, was approved by the FDA in April 1999. Unlike most other protease inhibitors that have to be taken three times daily, Agenerase has a long half-life and can be given twice daily.
Millions of Americans, particularly those between the ages of 40 and 60, suffer from onchomycosis, a persistent fungal infection of the nails. It occurs when dermatophyte fungi, usually Trichophyton rubrum, invade the nail bed. Men and the elderly are afflicted most often, although the infection can strike all ages and women as well.
Brand Name: Novantrone Active Ingredient: mitoxantrone Indication: Treatment of patients with multiple sclerosis Company Name: Immunex Corporation Availability: FDA approval of Novantrone for multiple sclerosis on January 31, 2000. Novantrone is already marketed for the treatment patients with pain related to advanced hormone-refractory prostate cancer (when used with corticosteroids) and as part of initial combination treatment of acute nonlymphocytic leukemia in adults.
As the population ages, the need for effective pain relief from osteoarthritis – which currently affects 80% of Americans over age 65 — is expected to increase. Millions of people are still searching for an effective treatment they can tolerate.
Blood clots in the veins, especially in the legs, are a common and very serious problem that affects some 5 million Americans each year. Such deep vein thrombosis (DVT) can lead to pulmonary embolism (a blood clot that travels to the lungs), which develops in about 500,000 people each year and is fatal in some 50,000 of them.
During a migraine headache attack, brain activity changes induce inflammation of cerebral blood vessels and nerves. Attacks may be triggered by alcohol, certain foods, too much or too little sleep, menstruation, emotional stress, or environmental factors.