The FDA found AcelRx Pharmaceuticals’ sublingual sufentanil tablets to be efficacious for moderate-to-severe acute pain but had concerns over the maximum dosing and the risk of misplaced tablets due to their small size. AcelRx and the FDA have both proposed a REMS program for sublingual sufentanil tablets. The FDA’s the Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to recommend approval of sublingual sufentanil tablets.
The NDA and MAA have been accepted for AbbVie’s sponimod for the treatment of Type 2 Diabetes Mellitus, Nephropathy. The FDA is expected to make a decision on sponimod in March 2019.
The FDA rejected Acacia Pharma’s amisulpride’s NDA on 10/8/18 due to manufacturing issues.
An FDA review of Trevena’s oliceridine was skeptical that the drug had less respiratory depression than morphine. The highest dose (0.5mg) appeared to be less efficacious than morphine in analgesic effects, but similar in ADR. Lower doses had few ADR, but less analgesic effects. All strengths of oliceridine provided more analgesic effect than placebo. The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 8-7 against recommending approval of oliceridine ahead of the November 2, 2018 PDUFA Date.
Ardelyx announced that in a Phase III, safety trial, the most common ADR with tenapanorwas diarrhea.
In the 2-year, 837 patient, Phase III, VOYAGER 1 trial, patients were randomized to placebo, guselkumab or adalimumab. After 16 weeks, placebo patients were switched to guselkumab. After 52 weeks adalimumab patients were switched to guselkumab. At 100 weeks, results were similar among patients that switched from placebo or adalimumab to guselkumab. Efficacy was measured using the Psoriasis Area and Severity Index (PASI) and the Investigator's Global Assessment (IGA) scales. Overall PASI 75 was achieved by 94.8% of patients, PASI 90 by 82.1%, PASI 100 by 49.0%, IGA 0/1 by 82.4% and IGA 0 by 53.8% at week 100 in patients with moderate to severe psoriasis.
In a 6-month Phase I/II trial, Pluristem Therapeutics’ PLX-PAD increased muscle volume by 300% and muscle force by 500% in patients with injured gluteal muscles after hip replacement. 2-year data from the study found better functional improvement with the lower dose most likely due to increased late‐onset immune reactivity with the higher dose.
Menlo announced that in a Phase II trial, serlopitant did not improve 24-hour cough frequency compared to placebo in patients with chronic cough.
J&J has an ongoing Phase III trial testing esketamine for treatment-resistant depression and major depressive disorder with imminent risk of suicide. J&J filed an NDA for esketamine in September 2018 and an MAA in October 2018. The drug does not have a PDUFA Date but does have a Breakthrough Therapy Priority Designation. Find more information about the efficacy and safety of esketamine along with links to two studies in PubMed in the Pharmaceutical Pipeline Tracker for as little as $115 per month with no annual commitment. https://www.prescriberight.com/subscription-offers.html
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