Safety before efficacy

September 20, 2005

Eli Lilly and Alkermes’ rival formulation to Pfizer’s inhaled insulin, Exubera, has cleared a Phase II clinical trial.

Eli Lilly and Alkermes' rival formulation to Pfizer's inhaled insulin, Exubera, has cleared a Phase II clinical trial. The results have spurred on Lilly and Alkermes to enter Phase III trials where, unusually, safety will take precedence over efficacy. Here, Lilly hopes to capitalize on Pfizer's 'weaknesses' by using a design that will bypass the problems that delayed Exubera getting to market, such as establishing the safety of long-term use on the lungs of diabetics.

Two Phase III trials will be conducted on Lilly and Alkermes' formulation: one in Type 1 (insulin-dependent) diabetics and the other in Type 2 (noninsulin-dependent) diabetics. The two companies hope the studies will demonstrate that their system will encourage patients to use a therapy that best improves glucose control.

www.lilly.com

Related Content:

Drug Delivery | Development