Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Neothetics has started the post-treatment safety and duration of effect study, LIPO-202-CL-23, of the first non-invasive injectable drug candidate 'LIPO-202' to reduce central abdominal bulging due to subcutaneous fat in non-obese subjects.
Subscribe to our email newsletter
LIPO-202 is an injectable formulation of salmeterol xinafoate, a long-acting ß2-adrenergic receptor agonist used in several FDA-approved drugs, including Advair, which is indicated to treat asthma.
In the second half of next year, the company intends to submit this supplemental safety study to the US Food and Drug Administration (FDA) as part of its new drug application (NDA) package for LIPO-202.
Neothetics chief medical officer Lincoln Krochmal said: "The achievement of this milestone highlights the traction of our Phase III Pivotal Program, AbCONTOUR1 and AbCONTOUR2.
"We are committed to develop LIPO-202 as the first non-invasive drug treatment for abdominal body contouring."
The double-blind extension trial will evaluate the post-treatment safety and duration of clinical effect of LIPO-202 in subjects who have completed either AbCONTOUR1 (LIPO-202-CL-18) or AbCONTOUR2 (LIPO-202-CL-19).
The LIPO-202-CL-23 trial will evaluate the post-treatment safety profile of LIPO-202 for up to one year post-treatment.
Secondarily, the company will be evaluating post-treatment duration of clinical effect of LIPO-202.
In the trial, subjects will be evaluated up to one year at three, six, nine, and twelve month intervals from baseline, while for the safety and duration of effect of LIPO-202, all study subjects will be evaluated at three months.