|
March 25, 2003. A pharmacokinetic investigation of inhaled insulin suggests that insulin absorption differs between cigarette smokers and nonsmokers. The impact of these data on efficacy remains to be seen, but the results imply that effective doses of insulin delivered by inhalation will differ, all else being equal, between smoking and nonsmoking patients. These findings confirm the complexities of inhaled insulin dosing in smokers versus nonsmokers.
In this study, NovoNordisk’s (NYSE: NVO) NN1998 inhaled insulin was delivered by Aradigm’s (NASDAQ: ARDM) AERx insulin Diabetes Management System (iDMS). The clinical trial was a randomized, crossover study in 27 nondiabetic smokers and 16 nonsmokers with a mean BMI 23.0 kg/m2. Study subjects received single inhaled insulin doses (33.8 IU) on consecutive days each following overnight fasting. On one day, smokers smoked three cigarettes immediately before insulin administration and on the other day, smokers had not smoked since midnight.
The amount of insulin absorbed during the first 6 hours after dosing (area under the curve from 0 to 6 hours) was significantly greater in smokers (by approximately 60%, p=0.0017). Moreover, peak concentration was both higher and earlier in smokers (maximal serum concentration, p< 0.0001) and the time to maximal serum insulin concentration was also significantly earlier (p=0.0003).
Although no safety issues arose in this investigation, these data support more extensive investigation of the matter in diabetic smokers who might be at greater risk of hypoglycemia at doses safe for non-smokers or even in smokers with normal glucose tolerance. It must be also noted that 17 study subjects (40%) reported mild or moderate adverse events, although none withdrew from the study due to adversities.
We have not been impressed with clinical trial data generated by NN1998 or other inhaled insulin formulations. The lead formulation is Exubera from Nektar (NASDAQ: NKTR), Pfizer (NYSE: PFE), and Aventis (NYSE: AVE). Exubera and NN1998 both have a modestly lower that average probability of timely clinical trial success and timely regulatory review compared to other drugs in phase III trials.
|
DISCLAIMER
The above information transmitted via BioPortfolio has been provided by the original publishers
BiotechTracker ("BT") a financial information, news, and
software service focusing on event-driven biotechnology and
pharmaceutical research. The Service is provided by DPBT, LLC
("DPBT"). a joint venture formed between BT Investor,
Inc. and PCS Research Technology, Inc.
It is not guaranteed as to completeness or accuracy by BioPortfolio, the
BT publishers, or any person. Such Information is neither an offer to sell nor a solicitation to buy the securities of any company. Opinions expressed are subject to change without notice. The Information and views provided by
BT are prepared by BT employees and in no way reflect the views or efforts of BioPortfolio Limited., any of BioPortfolio's employees or officers. BioPortfolio, and BioPortfolio's employees and officers, as well as
BT’s employees and officers, in no way accept responsibility for any of the
BT content published on
www.bioportfolio.com/.
While all reasonable care has been taken to ensure that the Information contained herein is presented in good faith, and is not untrue or misleading at the time of publication, BioPortfolio, and
BT make no representation as to its accuracy or completeness and it should not be relied upon as such. The Information is supplied on the condition that the reader or any other person receiving the Information will make his or her own determination as to its suitability for any purpose prior to any use of the Information. From time to time, BioPortfolio and any officers or employees of BioPortfolio, as well as
BT, and any officers or employees of BT, may, to the extent permitted by law, have a position or otherwise be interested in any transactions, in any investments (including derivatives) directly or indirectly the subject of this report. Also BioPortfolio and
BT may, from time to time solicit business from any company mentioned in this report. This report is provided solely for the information of viewers of BioPortfolio and/or viewers and subscribers of
BT and BioPortfolio information services, who are expected to make their own investment decisions without reliance on this report. Neither BioPortfolio nor any officer or employee of BioPortfolio, nor
BT, or any officer or employee of BT, accepts any liability whatsoever for any direct, indirect, special or consequential damages or loss arising from any use of this report or their contents. This report may not be reproduced, distributed or published by any recipient for any purpose without the prior express consent of the publishers. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent, trademark or copyright of BioPortfolio,
BT or any third party.
The value of the investment(s) to which this report relates and their income
yield(s) may go up or down. The investment(s) referred to in this report may not be suitable for private investors: if you are in any doubt you should seek advice from your investment advisor. Changes in rates of currency exchange may have an adverse effect on the value, price or income of investments. Statements as to past performance of any investment are not a guide to future performance. The levels and bases of taxation can change, and if you are in doubt you should seek independent professional advice. In some cases it may be difficult for you to sell or realize your investment or to obtain reliable information about its value or the extent of the risks to which you are exposed.
THIS INFORMATION IS PROVIDED "AS IS" AND NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED OF ACCURACY, MERCHANTIBILITY FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER NATURE ARE MADE WITH RESPECT TO THIS INFORMATION OR TO ANY EXPRESSED VIEWS PRESENTED IN THIS INFORMATION. |
