Hydexor (promethazine/hydrocodone/acetaminophen) / Charleston Labs - LARVOL DELTA

Prevention of Opioid-Induced Nausea and Vomiting During Treatment of Moderate to Severe Acute Pain: A Randomized Placebo-Controlled Trial Comparing CL-108 (Hydrocodone 7.5 mg/Acetaminophen 325 mg/Rapid-Release, Low-Dose Promethazine 12.5 mg) with Conventional Hydrocodone 7.5 mg/Acetaminophen 325 mg. (PubMed, Pain Med) - "There were no unexpected or serious adverse events. CL-108 is a safe and effective combination analgesic/antiemetic for the prevention of OINV during treatment of moderate to severe acute pain."

Clinical • Journal • Pain

A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions (clinicaltrials.gov) - P1; N=19; Completed; Sponsor: Charleston Laboratories, Inc

New P1 trial • Biosimilar

Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. initiate two phase 3 clinical trials on Charleston's lead product, CL-108 (PRNewswire) - "Charleston Laboratories...Daiichi Sankyo, Inc., initiated two Phase 3 clinical trials on CL-108...The studies will evaluate the safety and efficacy of CL-108, the first of its kind intended to treat moderate to severe acute pain while reducing nausea and vomiting..."; Anticipated NDA filing with the FDA later next year for moderate to severe acute pain.

Trial initiation date • Pain

A Rare Case of Gastric Sarcoidosis (ACG 2019) - "Labs showed hemoglobin 8.9, MCV 57, iron level 11, Na 138, Cl 108, and CO2 20...The patient was initially started on prednisone 40 mg daily tapering dose and had near immediate resolution of symptoms with increase in weight...For recurrence of symptoms, surveillance endoscopy is warranted to examine extent of disease. As in our patient, there is excellent response to glucocorticoid treatment and patients should be monitored clinically with tapering doses."

Clinical