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Biotech / Medical : ARADIGM CORP. ARDM -- Ignore unavailable to you. Want to Upgrade?


To: rkrw who wrote (218)9/17/2004 11:01:36 AM
From: tuck  Read Replies (1) | Respond to of 255
 
[Inhaled morphine delivered using the AERx system in patients with moderate-to-severe asthma]

>>Int J Clin Pharmacol Ther. 2004 Aug;42(8):456-62.

Safety and pharmacokinetics of inhaled morphine delivered using the AERx system in patients with moderate-to-severe asthma.

Otulana B, Okikawa J, Linn L, Morishige R, Thipphawong J.

Aradigm Corporation, Hayward, CA 94545, USA. totulana@aradigm.com

OBJECTIVE: The safety and pharmacokinetics of inhaled morphine in asthmatic subjects were investigated using the AERx System, a novel aerosol system. METHODS: Twenty subjects with asthma received inhaled placebo and inhaled morphine sulfate, 2.2 mg, 4.4 mg and 8.8 mg, on separate days in a single-blind crossover study. Six of the subjects received an additional open-label dose of 17.6 mg on a separate day. Plasma morphine concentrations and safety evaluations including pulmonary function testing were performed. RESULTS: Mean tmax values were similar following all dose groups at approximately 1-2 minutes. Mean AUC(0-->1) values showed dose proportionality for the first 3 dose groups (6.3, 12.3 and 24.3 ng x h x ml(-1)), the mean AUC(0-->1) for the 17.6 mg dose group was 1.6x that of the 8.8 mg dose group. No statistically significant differences in forced expiratory volume in 1 sec (FEV1) were found for the 2.2 mg, 4.4 mg, or 8.8 mg dose groups; at 17.6 mg, a statistically significant but not clinically meaningful reduction in mean FEV1 (-8.18%) from baseline occurred at 10 minutes compared to placebo, spontaneously returning to baseline by 60 min. Four subjects experienced significant but reversible decreases in FEV1 of > or = 20% compared to baseline and across all dose levels including after placebo, but with no associated increase in dyspnea, wheezing or other adverse events. CONCLUSIONS: Inhaled morphine using the AERx System was absorbed rapidly and demonstrated dose-dependent plasma concentrations. It was well-tolerated and did not cause clinically significant bronchoconstriction in most subjects with moderate-to-severe asthma.<<

Cheers, Tuck



To: rkrw who wrote (218)11/10/2004 11:44:12 AM
From: tuck  Read Replies (1) | Respond to of 255
 
>>VALENCIA, Calif., Nov. 10 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD - News) today announced at the CIBC World Markets Fifteenth Annual Healthcare Conference that it recently held an "End of Phase 2" meeting with U.S. Food and Drug Administration (FDA) officials to discuss the Company's Technosphere® Insulin System, which is under development to administer insulin by inhalation for the treatment of diabetes mellitus.

Dr. Wendell Cheatham, Corporate Vice President and Chief Medical Officer of MannKind Corporation, said he was pleased with the FDA meeting, commenting that "the discussions focused on our plans for pivotal Phase 3 clinical development of the Technosphere® Insulin System, which is expected to include two years of safety data from a subset of trial patients with type 1 and with type 2 diabetes at the time of submission of a new drug application."

"MannKind completed its current U.S. Phase 2b study in October and we will present the final efficacy and safety data from that study to the FDA in the coming weeks. We plan to begin a series of Phase 3 and special population studies in Europe and in the United States. The first ex-U.S. Phase 3 trial is planned to begin by year-end, and the first U.S.-based Phase 3 study is planned to begin by mid-2005," Dr. Cheatham added.<<

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Cheers, Tuck