US-based pharmaceutical firm Neothetics has started an open-label trial to evaluate the safety of multiple courses of LIPO-202 (salmeterol xinafoate for injection) treatment for the reduction of central abdominal bulging.
LIPO-202 is indicated for central abdominal bulging due to subcutaneous fat in non-obese subjects, an indication for which there is no FDA-approved drug.
Neothetics president and chief executive officer George Mahaffey said: "LIPO-202 has demonstrated an extremely clean safety profile, equivalent to placebo in the six clinical trials conducted to date, and this study will give us insights about the safety of multiple courses of treatment."
The company said that this is a supplemental study that it expects to submit to the US Food and Drug Administration (FDA) as part of its new drug application (NDA) package for LIPO-202.
The open-label trial will include three, eight-week courses of treatment with LIPO-202 with a three- month period between treatments in non-obese adult subjects who have central abdominal bulging.
Each course of treatment includes 20 subcutaneous 1mL injections of LIPO-202 (0.02mcg salmeterol xinafoate/mL; total dose of 0.40mcg salmeterol xinafoate), administered once a week.
The company intends to enrol 150 subjects at multiple centres in the US and the trial uses the same dose of drug to be used in its pivotal Phase III safety and efficacy trials.
According to the company, if LIPO-202 is approved it would be a best-in-class non-surgical, non-ablative procedure and first-in-class injectable formulation for localized fat reduction and body contouring.