Comes about because of a Phase 2 examine evaluating the consequences for blood glucose levels of Flexion Therapeutics' (NASDAQ:FLXN) lead item competitor, Fast Track-labeled Zilretta (FX006), in grown-up sort 2 diabetics with osteoarthritis (OA) of the knee demonstrated a measurably noteworthy and clinically important decrease in the ascent of blood glucose contrasted with quick discharge (IR) triamcinolone acetonide (TCA) (manufactured corticosteroid).
The study randomized 33 patients 1:1 to get either a solitary intra-articular infusion of 40 mg Zilretta or 40 mg IR TCA. Blood glucose levels were assessed for three weeks with a constant glucose checking gadget. The essential endpoint was the adjustment in normal glucose values from benchmark to 72 hours post dosing.
Finish results will be submitted for presentation at a future logical gathering.
Zilretta is a novel, non-opioid, supported discharge, intra-articular definition of triamcinolone acetonide in light of microsphere innovation that joins a polymer with a corticosteroid to give long haul torment alleviation. In late-arrange concentrates on it has shown clinically important change in torment, firmness and capacity in patients with knee OA. Prompt discharge corticosteroids can bring about a spike in blood glucose which can be hazardous for diabetics.
The organization arrangements to document a New Drug Application (NDA) with the FDA this quarter.
Beforehand: FDA OK with Flexion's information supporting NDA petitioning for lead item competitor Zilretta, accommodation on track for Q4; shares up 18% premarket (May 26)
Presently read: Cempra: FDA posts instructions docs for Nov. 4 Solithromycin AdCom »
The study randomized 33 patients 1:1 to get either a solitary intra-articular infusion of 40 mg Zilretta or 40 mg IR TCA. Blood glucose levels were assessed for three weeks with a constant glucose checking gadget. The essential endpoint was the adjustment in normal glucose values from benchmark to 72 hours post dosing.
Finish results will be submitted for presentation at a future logical gathering.
Zilretta is a novel, non-opioid, supported discharge, intra-articular definition of triamcinolone acetonide in light of microsphere innovation that joins a polymer with a corticosteroid to give long haul torment alleviation. In late-arrange concentrates on it has shown clinically important change in torment, firmness and capacity in patients with knee OA. Prompt discharge corticosteroids can bring about a spike in blood glucose which can be hazardous for diabetics.
The organization arrangements to document a New Drug Application (NDA) with the FDA this quarter.
Beforehand: FDA OK with Flexion's information supporting NDA petitioning for lead item competitor Zilretta, accommodation on track for Q4; shares up 18% premarket (May 26)
Presently read: Cempra: FDA posts instructions docs for Nov. 4 Solithromycin AdCom »
No comments:
Post a Comment
Note: only a member of this blog may post a comment.