Atrix Laboratories Inc has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) for an Atrigel formulation of octreotide, which is designed to deliver the pharmaceutical over a 30-day period.
Octreotide is the active compound in Sandostatin LAR Depot (octreotide acetate for injectable suspension) that is marketed by Novartis AG. Currently, the product is indicated for long-term treatment of symptoms associated with several disease states including malignant carcinoid syndrome.
"We are very excited about this formulation of octreotide," said Eric Dadey, vice president of drug delivery at Atrix. "In preclinical studies, this formulation of octreotide in the Atrigel system rapidly achieves and maintains therapeutically relevant levels of octreotide without the common 'lag' phase. We are pleased to be moving this product forward into Phase I human clinical trials."
David R. Bethune, Atrix's chairman and chief executive officer commented, "U.S. sales of Sandostatin were roughly $425 million in 2002. Worldwide sales were approximately $608 million, a 15.6 percent increase over 2001. Based on what looks like an excellent formulation and an excellent market opportunity, we are accelerating our time line to develop this product."
Atrix has formulated octreotide with its proprietary Atrigel sustained-release drug delivery technology. Atrigel consists of biodegradable polymers dissolved in a biocompatible carrier. Atrigel, when mixed with an active compound, is injected as a liquid, then solidifies into an implant that biodegrades, releasing drug over a pre-determined timeframe.