Drug Criteria & Outcomes-In The Pipeline
Drug Criteria & Outcomes-In The Pipeline
The following drugs are still in clinical trials:
- Metastatic colorectal cancer treatment UFT capsules (tegafur and uracil) by Bristol-Myers Squibb. FDA's Oncologic Drug Advisory Commit tee has recommended approval of first oral combination therapy, UFT capsules in conjunction with leucovorin calcium tablets for treatment of colorectal cancer. Phase III trials compared regimen to IV 5-FU and IV leucovorin. Median survival times in trial of 1,200 patients were similar (12.4 months vs. 12.6 months) in respective oral and IV groups. Major side effects such as myelosuppression, stomatitis, and mucositis were decreased in oral group, while common side effects such as diarrhea and nausea were statistically similar.
- Pediatric asthma treatment budesonide inhal ation suspension by AstraZeneca. FDA has accepted for review trials of nebulized corticosteroid aimed at gaining approval as first inhalant for patients under age 4. Submission follows a 12-week trial of 359 patients ages 6 months to 8 years receiving 0.25, 0.5, 1 mg or placebo once daily. Improvements in day and night asthma symptoms and decreased use of bronchodilaters were noted. Common side effects included respiratory infection, fever, sinusitis, and rhinitis.
- Hepatitis A/B combination vaccine Twinrix (Hepatitis A Inactivated & Hepatitis B Recom binant Vaccine) by SmithKline Beecham. FDA is reviewing licensing application for the vaccine, which, compared to current separate vaccine regimens, reduces total injections from five to three over six months. In randomized trial of 773 patients, similar antibody response was found between combination vaccine and Hepatitis A vaccine Havrix and Hepatitis B vaccine Engerix.
- Investigational antibiotic Zyvox (linezolid) by Pharmacia & Upjohn. Formulated against gram-positive bacteria for adult and pediatric use. One phase III trial of 397 patients with hospital-acquired pneumonia, IV linezolid and aztreonam showed a 66.4 clinical success rate, comparable to IV vancomycin plus aztreonam. In a community-acquired pneumonia trial, an IV to oral linezolid regimen resulted in a 90.8% success rate. Use against vancomycin-resistant Enterococcus resulted in 73.7 and 88.6% success rates in 200 mg and 600 mg doses respectively.
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