gabapentin (Assertio, 82da2b)

Gabapentin Extended Release (G-ER), specifically developed under the brand name Serada, is a gastric-retentive formulation of gabapentin designed by Assertio (formerly Depomed) for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) in postmenopausal women. The drug utilizes the AcuForm delivery technology, which allows the tablet to swell and be retained in the stomach, providing a steady release of gabapentin into the upper small intestine, its primary site of absorption. Gabapentin's mechanism involves binding to the alpha-2-delta-1 and alpha-2-delta-2 subunits of voltage-gated calcium channels, which is thought to stabilize thermoregulatory centers in the hypothalamus. Despite achieving significant results in the Phase III BREEZE clinical trial program, the FDA issued a Complete Response Letter in 2013 citing insufficient evidence of a clinically meaningful benefit relative to its safety profile, leading to the termination of its development for this indication.

Brand names

Serada

Other names

Gabapentin Extended ReleaseGabapentin ER