- Drug development company Paradigm Biopharmaceuticals (PAR) has received feedback from US Food and Drug Administration (FDA) for its knee osteoarthritis drug
- The FDA said there is one outstanding question about the adrenal gland function and wants PAR to modify its adrenal screening and mitigation plan
- The company will amend its clinical trial protocol, including all the FDA’s requests, and respond to the FDA within the next week
- Paradigm is expecting the FDA to take about 30 days to respond to these changes
- PAR was trading 6.19 per cent lower at $2.10 per share at 10:41 am AEST
Paradigm Biopharmaceuticals (PAR) has received feedback from US Food and Drug Administration (FDA) for its knee osteoarthritis drug.
Earlier this year, the company submitted an investigation new drug (IND) submission for pentosan polysulfate sodium (PPS).
Since then the FDA has asked a few questions about the product, with PAR answering them all.
Now it has given its feedback to PAR saying that there is one outstanding question about the adrenal gland function.
This question relates to a preclinical finding in the adrenal gland of rats only and was not seen in the adrenal gland of dogs.
“Adrenal gland malfunction has not previously been seen by Paradigm or bene
pharmaChem in their ongoing pharmacovigilance,” the company said.
Notably, this one preclinical finding has been the focus of the ongoing FDA review.
The FDA has now requested modifications to Paradigm’s adrenal screening and mitigation plan. The company will amend its clinical trial protocol, including all the FDA’s requests, and respond to the FDA within the next week.
Paradigm is expecting the FDA to take about 30 days to respond to these changes.
CEO Paul Rennie commented on the announcement.
“Although we understand the agency’s obligations for thorough reviews which
commenced in March of this year, I am confident that the FDA and Paradigm have now attained a pathway to commence our phase three clinical trial in the US,” he said.
PAR was trading 6.19 per cent lower at $2.10 per share at 10:41 am AEST.