Opioid-induced constipation (OIC) is among a handful of functional gastrointestinal disorders that have galvanized drug development efforts in recent years. Shionogi & Co. Ltd. is now looking to make its mark in the space.
A joint statement issued by Massachusetts Gov. Charlie Baker, chair of the National Governors Association's (NGA) Health and Human Services Committee, along with New Hampshire Gov. Maggie Hassan, the committee's vice chair, and Patrice Harris, chair-elect of the American Medical Association (AMA), placed another thorn in the side of the FDA a day after Titan Pharmaceuticals Inc. and partner Braeburn Pharmaceuticals Inc. disclosed that the agency extended by three months the PDUFA date for Probuphine, designed for the maintenance treatment of opioid addiction.
Opioid-induced constipation (OIC) is among a handful of functional gastrointestinal disorders that have galvanized drug development efforts in recent years. Shionogi & Co. Ltd. is now looking to make its mark in the space.
In a telling example of the growing importance of the gastrointestinal market, the main quibbles during the recent Arthritis Advisory Committee (adcom) meeting to discuss the application for CT-P13 (infliximab) – Celltrion Inc.'s biosimilar to Remicade (infliximab, Janssen Biotech Inc.) – focused more on the FDA's willingness to extrapolate clinical findings in rheumatoid arthritis and ankylosing spondylitis to inflammatory bowel disease (IBD) and related GI conditions than to the indications supported by clinical studies.
Within the gastrointestinal (GI) space, inflammatory bowel disease (IBD) and its major constituents of ulcerative colitis and Crohn's disease remain bigger and easier targets for biopharma than irritable bowel syndrome (IBS) and related functional GI disorders, as evidenced by the number of drug trials sponsored by companies – approximately 800 in IBD compared to just over 100 targeting IBS, diarrhea-predominant IBS (IBS-D) and constipation-predominant IBS (IBS-C), according to Cortellis Clinical Trials Intelligence.
Individuals with complete spinal cord injuries face a lifetime of complications, not the least of which is fecal incontinence. But those patients – approximately 250,000 in the U.S. who live with the condition, four out of five of them men – represent just the tip of the iceberg for those with rectal diseases, including anal fissures and fistulas.
Flexion Therapeutics Inc. looked to move Zilretta (FX006) over the goal line after a damaging pivotal phase IIb miss in late 2015 by reporting findings from an initial phase III showing that the injected intra-articular (IA) sustained-release, non-opioid, non-steroid treatment achieved clinically meaningful and highly statistically significant separation from placebo in treating moderate to severe osteoarthritis (OA) knee pain at each measured time point in weeks one through 16, meeting the primary endpoint at week 12 with a "p" value of
Third Rock Ventures LLC planted yet another seed in its garden of flourishing start-ups by forming Pliant Therapeutics Inc. with a $45 million series A designed to advance multiple small molecules and propel its lead candidate through investigational new drug (IND)-enabling studies in idiopathic pulmonary fibrosis (IPF).
In a telling example of the growing importance of the gastrointestinal (GI) market, the main quibbles in last week's Arthritis Advisory Committee (adcom) meeting to discuss the application for CT-P13 (infliximab) – Celltrion Inc.'s biosimilar to Remicade (infliximab, Janssen Biotech Inc.) – focused more on the FDA's willingness to extrapolate clinical findings in rheumatoid arthritis and ankylosing spondylitis to inflammatory bowel disease (IBD) and related GI conditions than to the indications supported by clinical studies.
