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Neurocrine Biosciences Presents Data on In Vitro Dissolution Performance of INGREZZA® (valbenazine) Capsule Contents via Soft Foods or Feeding Tube at AMDA - PALTC 2023 Annual Conference
SAN DIEGO, March 9, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced it will present data from three in vitro dissolution
About this update from Neurocrine Biosciences, Inc.
[{"type":"text","content":"SAN DIEGO, March 9, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced it will present data from three in vitro dissolution studies exploring the dissolution performance of INGREZZA® (valbenazine) capsule contents through soft foods or a gastrostomy (G-tube) feeding tube. The data (Poster #IND03, Valbenazine Capsule Contents for Potential Administration via Soft Food/Feeding Tube) will be presented at AMDA – The Society for Post-Acute and Long-Term Care Medicine's PALTC23 Annual Conference being held March 9-12 in Tampa, Florida.\n\n \n \n \n \n \n \n\n \nThe in vitro data demonstrated that crushing INGREZZA capsule contents did not impact dissolution performance when compared to whole capsules. Further, mixing the contents with soft foods or liquids of a broad pH range or delivering the contents dissolved in tap water via G-tube resulted in acceptable dissolution performance of INGREZZA.\n\"The data presented show that crushing the capsule contents of INGREZZA did not impact the dissolution performance in comparison to swallowing whole capsules in vitro,\" said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. \"This information may be important for patients with tardive dyskinesia, especially those who are elderly, who may have trouble swallowing capsules because of their abnormal movements or other comorbid conditions.\"\nThree studies were conducted to explore the potential of adding crushed INGREZZA capsule contents to soft foods or a gastrostomy feeding tube (G-tube):\nIn Study 1, INGREZZA capsules could be opened manually, with the contents crushed between spoons. Very rapid and complete drug release (>98 percent in 15 minutes) was observed in all samples, independent of preparation (whole capsules or crushed contents) or dose (40 mg or 80 mg). For both doses, the average percentage release at first and last collection time points (10 minutes and 60 minutes, respectively) was similar for whole vs crushed in each of two commercial lots of INGREZZA (Lot-A, Lot-B) for the two doses (40 mg and 80 mg)In Study 2, recovery of crushed INGREZZA capsule contents was acceptable within 2 hours of adding them to the tested foods and buffers/fed state simulated gastric fluid (FeSSGF) (assay recovery range: 92 to 102 percent). Degradants of crushed contents in foods and buffers/FeSSGF we...