Bentley Pharmaceuticals, a US specialty pharmaceutical company, has received approval from the Drug Controller General of India to proceed with a Phase II clinical evaluation of its Nasulin in type 2 diabetic patients. Nasulin is the company's intranasal insulin product utilizing its proprietary CPE-215 delivery technology.
This follows the completion of its pharmacokinetic clinical studies of Nasulin studies in India. The 12-week Phase II study will be initiated in March and is expected to be completed before the end of 2007.
John Sedor, president of Bentley commented: "this expansion marks an incremental milestone in the clinical development of our Nasulin. We are encouraged by the progression of data we've accumulated in the insulin program, which further validates our intranasal delivery technology platform and its potential to deliver other therapeutic peptides in similar formulations to insulin."
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