M2 EQUITYBITES-March 1, 2018-MAIA Pharmaceuticals wins US FDA's tentative approval for Sincalide for Injection NDA
Pharmaceutical company MAIA Pharmaceuticals Inc reported on Wednesday the receipt of the tentative approval from the US Food and Drug Administration (FDA) for its Sincalide for Injection NDA for the stimulation of gallbladder contraction.
According the company, Sincalide for injection is indicated in adults to:stimulate gallbladder contraction; stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition and cytology; as well as accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract.
M2 PHARMA-March 1, 2018-MAIA Pharmaceuticals wins US FDA's tentative approval for Sincalide
for Injection NDA
Sincalide is a synthetic C-terminal octapeptide analogue of CCK that is readily available commercially for parenteral use, which is used almost exclusively for diagnostic use in CCK-HBS.
This can be avoided by pretreating such patients with sincalide, infusing the total dose of 0.02 [micro]g per kilogram over 15 to 60 minutes intravenously.
If further dynamic imaging is required following intervention, such as for imaging during sincalide stimulation of the GB (stimulation phase), it is typically acquired and displayed similar to the hepatobiliary baseline phase.
These include dose of sincalide
(CCK) administered, duration of administration, and time at which GBEF is calculated.
The current standard of practice recommends fasting for a minimum of 4-6 hrs before HBS.40-42 If the patient has been fasting for greater than 24 hrs, then pretreatment with 0.02 mcg/kg sincalide (a synthetic analog of cholecystokinin) infused over 15 to 60 minutes, followed by a 20-min wait before radiotracer injection, 42 would evacuate the bile from the GB and facilitate reentry of freshly radiolabeled bile into the refilling GB.
In the first variation, the patient is first pretreated with sincalide followed 15 minutes later by simultaneous injection of morphine and the radiotracer.
In a study by Jadvar et al, (3) FDG PET scans were performed on normal subjects without intervention, with atropine to reduce peristalsis, and with sincalide (a cholecystokinetic) to promote peristalsis.
Effect of atropine and sincalide on the intestinal uptake of F-18 fluorodeoxyglucose.