The non-FDA approved and compounding pharmacy approach of the early 2000s for an injectable fat reduction concept (LipoDissolve) has long disappeared as a franchise concept. But the popularity of an injectable fat treatment was not forgotten. This has spurned into a more scientific approach to injectable lipolysis with several companies putting their drugs through the FDA regulatory process for approval.
One of these potential injectable fat melting drugs is Lipo-202 (Neothetics) which is being studied and in clinical trials for abdominal fat reduction. This is noteworthy because of Kythera’s ATX-101 recent FDA approval for submental fat reduction. Lipo-202 is for the reduction of central abdominal bulging due to subcutaneous fat in non-obese patients, known as a pot-belly or stomach pouch. There is currently no FDA-approved drug for the treatment of abdominal fat reduction.
Lipo-202 contains salmeterol xinafoate known for its use as a highly selective beta 2 adrenergic bronchodilator. (Severent Diskus) Adrenergic receptor stimlation is well known to increase lipolysis and is the historic basis for mesotherapy with the injection of adrenergic agonists like aminophylline, isoproterenol and caffeine.
An abdominal Lipo-202 treatment involves roughly 20 shots given with a very small needle. (30-gauge needle) The injections are dispersed evenly over the abdomen at about 4 cm intervals and are performed once a week for eight weeks. Each treatment takes about 5 minutes. Preliminary data suggest that the treatments produce measurable results as soon as 4 weeks from initial treatment and that the benefits last for a minimum of 3 months after treatment.
Lipo-202 will initiate Phase 3 clinical trials during 2015 with clinical data hopefully being ready for FDA submission by 2016.
Dr. Barry Eppley
Indianapolis, Indiana