December 27, 2000
ST. LOUIS (MD Consult) - The FDA announced last month its approval of a new indication for Botulinum Toxin Type A: the treatment of painful cervical dystonia. The approval clears the way for more widespread use of botulinum toxin--marketed by Allergan, Inc., as BOTOX--for a previously off-label indication.
Patients with cervical dystonia have involuntary muscle contractions that force the neck and head into abnormal, painful positions. Botulinum toxin alleviates these problems by blocking acetylcholine release from the nerve into the muscle.
In a phase III randomized trial, cervical dystonia patients treated with botulinum toxin had significantly greater improvement than those treated with placebo. The multicenter trial included 170 patients with cervical dystonia, which had been present for a mean of 11 years.
Adverse effects included a 19% rate of dysphagia, a 12% rate of upper respiratory infection, an 11% rate of both neck pain and headache. Botulinum toxin should be used cautiously in patients with peripheral motor neuropathies or neuromuscular junctional disorders, because they may be at increased risk of systemic effects.
The new approval addresses an indication for which botulinum toxin may have commonly been used off-label. Botulinum toxin treatment for cervical dystonia has been endorsed by the American Academy of Neurology and the Nationals Institutes of Health, and is an approved indication in 40 countries around the world.
Botulinum toxin is widely used for treatment of strabismus and blepharospasm. Allergan is exploring other indications, including specific neurologic diseases and cosmetic procedures.
November 21, 2000
ST. LOUIS (MD Consult) - Tamiflu (oseltamivir phosphate) has been approved by the FDA for the prevention of influenza A and B, according to drug-developers Hoffman-La Roche and Gilead Sciences. Tamiflu is now the only approved option for both flu treatment and prevention.
According to the developers, Tamiflu is up to 92% effective in preventing influenza with once a day dosing by adolescents, adults, and the elderly. With varied dosing of the same pill, indications for usage can vary. Treatment involves 75 mg twice a day for five days. Prevention requires 75 mg once a day for seven days post-exposure to influenza or 75 mg once a day for 42 days for seasonal protection.
Tamiflu is not officially recommended as a replacement for flu vaccinations. However, the current flu vaccine shortages throughout the country do provide a need for another protection option. For high-risk groups such as the elderly, Tamiflu can possibly provide a stop-gap measure this season.
FDA approval for Tamiflu came in October 1999 and the drug has since garnered more than 30% of the overall influenza antiviral market. Its closest rival, Glaxo Wellcome's inhaled antiviral Relenza (zanamivir), however, is already approved in the European market. Tamiflu will not be approved by European regulatory agencies in time for treatment this flu season. Therefore, Relenza will be the available option internationally this flu season.
April 19, 2000
FDA Adds Two New Drug Treatments to the Fight Against Osteoporosis
ST. LOUIS, (MD Consult) - The FDA has cleared for marketing the new drug Actonel for the treatment of osteoporosis and approved a new indication for Pharmacia & Upjohn's Activella.
Actonel (risedronate sodium tablets) is indicated in the treatment and prevention of postmenopausal osteoporosis and glucocorticoid-induced osteoporosis. Procter & Gamble, the inventor of Actonel, and Aventis Pharmaceuticals will market the drug collaboratively.
Actonel 5 mg is the first osteoporosis therapy to consistently demonstrate a reduction in vertebral fractures in just one year of treatment. Additionally, Actonel is the only therapy to show this one-year vertebral fracture benefit in patients with glucocorticoid-induced osteoporosis as well.
Actonel should not be used in patients with low blood calcium or in patients with severe kidney disease.
The FDA also approved Pharmacia & Upjohn's Activella for the new indication of the prevention of osteoporosis. Activella is a continuous-combined once daily tablet combining estrogen (1 mg estradiol) and progestin (0.5 mg norethindrone acetate). It was previously approved by the FDA for the treatment of moderate to severe vasomotor symptoms associated with menopause and for vulvar and vaginal atrophy associated with menopause.
Common side effects may include breast tenderness/pain, upper respiratory complaints, headache and postmenopausal bleeding.
April 3, 2000
ST. LOUIS, (MD Consult) - SmithKline Beecham announced on April 3, 2000, that the United States Food and Drug Administration (FDA) has approved the company's oral antidiabetes agent Avandia (rosiglitazone maleate) for use as a type 2 diabetes treatment in combination with sulfonylureas. Avandia has been previously approved for use as monotherapy or in combination with Metformin.
The addition of Avandia to sulfonylureas resulted in significant improvements in insulin sensitivity and estimates of beta-cell function in three randomized, double-blind, 6-month studies.
Adverse reactions to Avandia when used in conjunction with sulfonylureas was overall the same types of adverse events in patients prescribed monotherapy. Commonly reported adverse events were upper respiratory tract infections and headaches. As observed with other members of this glitazone class of drugs, improvements in glycemic control were associated with weight gain. Additionally, a low incidence of anemia and edema were reported.
March 13, 2000
ST. LOUIS, (MD Consult) - Duramed Pharmaceuticals announced on March 13, 2000, that the US Food and Drug Administration (FDA) had approved the company's supplemental new drug application for Cenestin (synthetic conjugated estrogens, A) Tablets for the 1.25 mg dosage strength. Cenestin, which was awarded FDA approval for the 0.625 mg and 0.9 mg strengths last year is Duramed's plant-derived, synthetic conjugated estrogens product for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.
"This is a significant approval for Duramed," said Chairman and Chief Executive Officer E. Thomas Arington. "The 1.25 mg price will be equal to the Cenestin 0.9 mg tablet, imposing no price penalty for the use of the higher dosage form."
Duramed successfully completed clinical trials in July 1999 that established the bioequivalence of one 1.25 mg strength tablet of Cenestin to two of the approved 0.625 mg Cenestin Tablets. Arington commented, "Our clinical trials found the 1.25 mg strength dose, which is proportional to the 0.625 mg tablets, to be essentially identical to the 0.625 mg strength in rate and extent of absorption of the active ingredients into the bloodstream."
Like all estrogen drug products, Cenestin Tablets should not be used in women with known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, or thromboembolic disorders. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women with an intact uterus. The most common adverse events reported in clinical experience with Cenestin included headache, insomnia, asthenia, nervousness, paresthesia, and depression.
Solvay Pharmaceuticals, Inc., based in Marietta, Ga., is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women's health. Duramed Pharmaceuticals develops, manufactures and markets prescription drug products. On October 6, 1999, Duramed entered into an alliance with Solvay Pharmaceuticals, Inc. to jointly promote three of the companies' hormone products to obstetricians and gynecologists across the United States: Duramed Pharmaceuticals' Cenestin and Solvay Pharmaceuticals' Estratest ® 2 and Prometrium ® 3.
February 28, 2000
ST. LOUIS, (MD Consult) - Aventis Pharma, the pharmaceutical company of Aventis S.A., announced on February 28, 2000, that it obtained US Food and Drug Administration (FDA) approval to market a once daily, 180 mg form of Allegra (fexofenadine) for patients over 12 years of age.
Allegra has also been approved by the FDA for two new indications:
Aventis S.A. (NYSE: AVE) is one of the world's leading life science companies, launched in December 1999 through the merger of Hoechst AG and Rhône-Poulenc S.A.
February 14, 2000
ST. LOUIS, (MD Consult) - The biologic response modifier interferon gamma-1b has received orphan-drug approval for an indication with few other treatment options: the rare congenital disorder osteopetrosis.
The approval, announced by the FDA, is based on studies showing that interferon gamma-1b effectively delays the time to disease progression in children with severe, malignant osteopetrosis. Interferon gamma-1b is marketed by InterMune Pharmaceuticals, Inc., as Actimmune Injection.
In a phase III clinical trial, 15 children with osteopetrosis were randomized to receive either interferon gamma-1b or calcitrol. Median time to disease progression was at least 165 days in the interferon gamma-1b group, compared with 65 days in the control group. The study definition of disease progression was death, reduction in hemoglobin or platelet counts, serious bacterial infection, significant hearing loss, or progressive optic atrophy.
Earlier trials showed that interferon gamma-1b has mild and manageable side effects, most commonly flulike symptoms.
Severe, malignant osteopetrosis is a rare congenital disease associated with bony overgrowth, leading to blindness, deafness, and a high number of infections. Many affected children will die before they are 10 years old.
Bone marrow transplantation has been the only treatment for osteopetrosis. However, transplantation is usually unsuccessful because of donor-recipient mismatches or pretransplant disease progression. The manufacturer hopes that interferon gamma-1b will prolong the lives of children with severe, malignant osteopetrosis, possibly offering time to find an optimal bone marrow donor.
The new approval offers a badly needed treatment alternative for osteopetrosis. Interferon gamma-1b was originally approved in 1990 for the treatment of chronic granulomatous disease. InterMune is also studying its use for other indications, including pulmonary fibrosis, multidrug-resistant tuberculosis, and systemic fungal infections.
February 4, 2000
ST. LOUIS, (MD Consult) - The US Food and Drug Administration (FDA) has approved Levaquin tablets/injection (levofloxacin) for the indication of the treatment of penicillin-resistant Streptococcus pneumoniae in patients with community acquired pneumonia (CAP).
This new indication makes Levaquin the first prescription antimicrobial agent specifically indicated for CAP caused by this resistant bacterium.
Levaquin has been marketed in the United States by Ortho-McNeil Pharmaceutical, Inc. since January 1997 for the treatment of mild, moderate and severe CAP caused by other pathogens, acute maxillary sinusitis and acute bacterial exacerbation of chronic bronchitis, in addition to mild to moderate uncomplicated skin and skin structure infections, complicated urinary tract infections, acute pyelonephritis and uncomplicated urinary tract infections.
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