In the company ™s final analysis of the data from the pivotal Phase 3 clinical trial in patients with Type 1 diabetes, patients receiving Humulin?® R were twice as likely to have one or more severe hypoglycemic events when compared to those receiving VIAject?®. This result did not achieve statistical significance due to the small number of patients experiencing one or more severe hypoglycemic events (15 patients in the Humulin?® R arm and 8 patients in the VIAject?® arm, for a total of twenty-three patients). Patients receiving VIAject?® lost 0.1 pounds on average, while patients receiving Humulin?® R gained 3.1 pounds on average, for a difference of 3.2 pounds. This result was statistically significant.
In the company ™s final analysis of the data from the pivotal Phase 3 clinical trial in patients with Type 2 diabetes, the median number of non-severe hypoglycemic events in the Humulin?® R arm was twice as great as in the VIAject?® arm. Patients treated with VIAject?® gained less weight than patients treated with Humulin?® R. Patients receiving VIAject?® gained 1.0 pounds on average, while patients receiving Humulin?® R gained 3.0 pounds on average, for a difference of 2.0 pounds. Both the hypoglycemia and weight results were statistically significant. With regard to severe hypoglycemic events, no meaningful comparison was possible due to the small number of events that occurred in both the VIAject?® and the Humulin?® R treatment groups.
Update on VIAject?® Formulation
Since completing the pivotal Phase 3 clinical trials, the company has developed other formulations of VIAject?® and successfully bridged from the pH 4, 25 IU/cc, two-vial lyophilized formulation used in the pivotal trials to a pH4, 100 IU/cc liquid formulation. Recently, the company successfully bridged to a pH 7 100 IU/cc liquid formulation upon which the NDA for VIAject?® will now be based. The pH 7 formulation may offer certain commercial advantages, including increased stability and greater tolerability. A recent tolerability study demonstrated a statistically significant reduction in injection site discomfort with the pH7 100 IU/cc liquid formulation of VIAject?® compared to the lyophilized formulation. A majority of patients in this tolerability study experienced the same or less discomfort with the liquid formulation of VIAject?® than they did with their usual meal-time insulin, although a subset of patients experienced more injection site discomfort with the liquid formulation of VIAject?® than they did with Humalog?®.
Biodel is developing the 100 IU/cc liquid formulation for use in two presentations: in vials for use with syringes and insulin pumps, and cartridges for use in both disposable and reusable pen injectors. The company recently executed a letter of intent to purchase a disposable insulin pen designed by Wockhardt Ltd. for use with VIAject?®. The company intends to submit this pen to the FDA for review subsequent to filing the VIAject?® NDA upon completing certain modifications that the company believes will improve its commercial performance.
SOURCE Biodel Inc.