FDA Extends PDUFA Date for Polyethylene Glycol Solution

FEBRUARY 12, 2018
Kevin Kunzmann
The US Food and Drug Administration (FDA) has extended its set PDUFA action date for the review of the New Drug Application (NDA) for an investigational bowel cleansing therapy.

The NDA for NER1006 (PLENVU), a novel, low-volume (1L) polyethylene glycol based bowel preparation designed to provide whole bowel cleansing for contribution to colonoscopy procedures, will now be decided on by May 13. The investigatory solution, licensed by Salix Pharmaceutical, was originally scheduled for a PDUFA date of February 13.

The PDUFA action date was extended the 3 months to allow the FDA more time to review supplemental clinical data for solution, which the administration had previously requested as part of the NDA process. Salix expressed intention to work with the FDA moving forward to support the solution’s NDA review.

The preparation solution was licensed by Salix from Norgine BV in August 2016, in its effort to reach the US market. If approved, it is anticipated the solution will support improved patient acceptability and compliance to bowel cleansing, as well as contribute to effective colonoscopy procedures by improving colon cancer detection.

In a multicenter, randomized phase 3 trial involving 621 adult patients, researchers compared the bowel cleansing efficacy, safety, and tolerability of NER1006 versus a trisulfate bowel cleansing solution using a two-day split-dosing regimen.

Patients were administered either NER1006 or the solution as a split dose, to have the evening before and on the day of their colonoscopy. The groups were measured for total patients with effective overall colon cleansing at the end of the 2 days of treatment, as assessed by a blinded colonoscopist using the Harefield Cleansing Scale (HCS).

Among the 276 patients to undergo NER1006 solution administration, 235 (85%; 97.5% CI; P = 0.529) reported effective bowel cleansing. Among the 280 patients to undergo the trisulfate solution, 238 (85%) reported effective bowel cleansing.

In a secondary endpoint testing for highly effective bowel cleansing as measured by colon ascendens (as measured on a scale of 0 to 4 with higher numbers meaning greater efficacy), 99 of 276 (36%) NER1006 patients reported scores of 3 or 4. In the trisulfate group, 82 of 280 (29%) reported scores of 3 or 4.

Serious adverse effects were severely limited in both patient groups, as just 1 patient on trisulfate solution reported gastrointestinal hemorrhage, and 1 NER1006 patient reported ileus. Another 35 patients (13%) administered NER1006 reported nausea or vomiting — the 2 most common adverse events.

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