US-based AcelRx Pharmaceuticals has started dosing in the pivotal Phase III trial of ARX-04, a non-invasive, single-use 30mcg sufentanil sublingual tablet in a disposable, pre-filled, single-dose applicator (SDA), for the treatment of pain.

Scheduled to be conducted at four sites in the US, the multi-center, double-blind, placebo-controlled SAP301 trial will evaluate the efficacy and safety of ARX-04 vs. placebo to treat moderate-to-severe acute pain following ambulatory abdominal surgery.

A total of 160 adult patients will be included in the trial and they will be randomised 2:1 active to placebo, to be treated for about 48 hours.

During the trial, ARX-04 or placebo will be administered by site staff as requested by the patient, but it will not be more than once per hour.

The trial’s primary endpoint is to show a significant difference in the time-weighted summed pain intensity difference (SPID) of ARX-04 compared to placebo over a 12-hour dosing period (SPID-12).

AcelRx founder and chief medical officer Dr Pamela Palmer said: "We are pleased to have our pivotal ARX-04 Phase III clinical trial underway.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

"The ARX-04 product represents a promising new application of our sublingual tablet technology for delivery of sufentanil and has the potential to safely provide non-invasive, fast-acting analgesia for patients in acute pain.

"We anticipate enrollment to take up to nine months. Pending the completion of enrollment in this study, we anticipate top-line results in the fourth quarter of 2015."

ARX-04 includes 30mcg sufentanil sublingual tablet, in a pre-filled SDA and the company’s tablet formulation enables sublingual sufentanil absorption when the drug is placed under the tongue.

As a result, ARX-04 can provide analgesia in a non-invasive method of administration and show a consistent pharmacokinetic profile due to a high percentage of drug being absorbed sublingually instead of through the gastrointestinal tract.