gabapentin (Assertio)

Gabapentin extended-release (ER) is a formulation of the GABA analogue gabapentin, developed by Depomed (now Assertio) using its proprietary Acuform gastroretentive drug delivery technology. This technology is designed to allow for once-daily dosing by swelling in the stomach and releasing the drug gradually into the upper small intestine, the primary site of gabapentin absorption. While gabapentin is traditionally used for epilepsy and neuropathic pain, Depomed investigated this specific ER formulation (under the proposed brand name Sereda) for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) in postmenopausal women. The clinical development program included the Phase 3 Breeze trials (Breeze1, Breeze2, and Breeze3). Despite meeting primary endpoints in some trials, the FDA issued a Complete Response Letter in 2013, citing that the efficacy was not robust enough to outweigh the risks, leading to the discontinuation of the hot flash program. The same formulation is currently approved for the management of postherpetic neuralgia under the brand name Gralise.

Brand names

SeredaGralise

Other names

Gabapentin Extended ReleaseGabapentin ERGabapentin Extended-Release