New Jersey-based Tris Pharma Inc has developed an oxybate formulation intended for the treatment of cataplexy or excessive daytime sleepiness in people with narcolepsy that boasts both once-nightly dosing and low sodium content. The Tris oxybate formulation is investigational and not currently approved by any regulatory agency.
According to Tris, the oxybate formulation contains less than 100 mg of sodium per 9.0 gm of maximum sodium oxybate equivalent dose. The company is pursuing an orphan drug designation for its oxybate formulation.
In a human clinical study, Tris states in a release that it established about 100% bioavailability for one dose of its formulation against two doses of Jazz Pharmaceuticals’ XYREM (sodium oxybate) at 4.5 gm each, equivalent to the 9.0 gm maximum dose of sodium oxybate.
The Tris oxybate product achieved its clinical objectives by combining two distinct proprietary Tris technologies: its “LiquiXR platform” and a newly developed “RaftWorks” design. Working together, these formulation platforms provide an interpenetrating network raft in-situ, in which sodium-free drug particles are entrapped in a raft that allows for extended release of the active ingredient.
According to Tris, many drugs, such as oxybate, are poorly absorbed because they have a narrow window of absorption within the human gastrointestinal tract. The RaftWorks approach permits a slow and extended release of oxybate from a floating raft in-situ, thereby facilitating absorption of the active ingredient within the targeted area in the gastrointestinal tract. Further, the raft disintegrates at a predetermined time due to the trigger mechanism that is built into the formulation, the company states.
“This unique formulation design by Tris scientists potentially achieves drug delivery capabilities that have never previously been achieved within our industry,” says Ketan Mehta, founder and CEO of Tris, in a release. “We are looking to build on this approach and develop extended-release formulations for other drugs that are limited by their narrow window of absorption.”