PIPELINE
Hybridon is enrolling 14 patients with relapsing CMV retinitis
for Phase I/II open-label, dose-ranging trial for three sites
in the United States. Hybridon's investigational new drug application
for the antisense oligonucleotide GEM 132 has received FDA approval
for the treatment of cytomegalovirus (CMV) retinitis, a disease
that results in blindness in nearly 40% of late-stage AIDS patients.
The company already has results from Phase I European trials involving
18 volunteers who each received an intravenous infusion of GEM
132 in increasing doses up to 0.5 mg/kg.
Maxim Pharmaceuticals, Inc. has filed an investigational new drug application with the FDA for permission to conduct a Phase II clinical trial for its H2-receptor agonist, Maxamine, for the treatment of malignant melanoma. The company hopes to demonstrate safety and effectiveness of Maxamine and measure time to disease progression, tumor response, duration of response, and overall patient survival. In the trial, the drug will be coadministered with cytokine, interleukin-2.
Zanamivir, Glaxo Wellcome's drug for treating the flu virus, is
expected to go to Phase III trials later this year. The company
currently is assessing in what patients the drug results in greatest
efficacy.
Tissue plasminogen activator (t-PA) recently became the first medicine approved by the FDA for stroke victims. Even though it costs about $2,200 per dose, the drug appears to save money. Used properly, it help prevent paralysis, speechlessness, and intellectual damage. It also appears to reduce hospitalizations and the need for rehabilitation services and nursing facility placement. Before this drug appears on the market, medical care for strokes mostly involved rehabilitation post-stroke, not stopping strokes in progress.
The FDA has approved a genetically engineered version of factor IX, a blood-clotting drug, for people with a rare form of hemophilia. This version of factor X, from Genetics Institute of Cambridge, will be marketed under the brand name, BeneFix. Some patients may need higher doses of BeneFix than factor X.
Norco tablets (hydrocodone bitartrate/acetaminophen 10 mg/325 mg) have received FDA clearance. Norco tablets, from Watson Laboratories, Inc., offer the highest single-tablet dose of hydrocodone bitartrate with the lowest level of acetaminophen of all 10 mg hydrocodone combination products for easing moderate to moderately severe pain.
Integrilin, an experimental heart drug from Cor Therapeutics, has failed to win the approval of an FDA advisory panel, who recently voted against recommending FDA approval of the drug. The panel said that the Cor did not provide enough proof of the drug's effectiveness.
IDEC Pharmaceuticals Corp. and Genentech Inc. have filed for FDA approval to market a new lymphoma treatment, IDEC-C2B8 (rituximab). This drug would be the first monoclonal antibody product in the U.S. to fight cancer in patients who have a relapse of slow-growing non-Hodgkin's lymphoma.
The FDA has granted tentative approval of an Abbreviated New Drug Application for Acyclovir in 400 and 800 mg tablets. IVAX Corp.'s Acyclovir is indicated for treating genital herpes, herpes zoster, and chicken pox.
The FDA recently has cleared changes to prescribing information for Claritin-D 12 Hour (5 mg loratadine, 120 mg pseudophedrine sulfate) and Claritin-D 24 Hour (10 mg loratadine, 240 mg pseudoephedrine sulfate) Extended Release Tablets. The medications now will be labeled as safe for use in seasonal allergic rhinitis patients with concomitant asthma. This change was approved based on the results of a six-week, placebo-controlled study of 193 patients with allergic rhinitis and concomitant asthma.
Late last year, Carter-Wallace's Astelin (azelastine HCI) nasal spray received FDA approval. Now the product is being launched in the U.S. as the first prescription antihistamine nasal spray in this market. Astelin is indicated for treating seasonal allergic rhinitis in adults and children over age 12. The recommended dose is two sprays per nostril twice per day. The most frequently reported side effects reported in trial were headaches, a bitter taste, somnolence, and nasal burning.
Idamycin-Pfs (idarubicin) has received FDA approval for the treatment of acute nonlymphomatic leukemia in adults in combination with other approved drugs for leukemia. The product is from Pharmacia and Upjohn.
Retin-A Micro (tretinoin gel microsphere .1%) has received FDA
approval for topical application in treating acne vulgaris. Ortho,
the product's manufacturer, will position the product as a potentially
less-irritating alternative to Retin-A (tretinoin cream .1%).