trending Market Intelligence /marketintelligence/en/news-insights/trending/pocraPoIV8Vi8bIuR22WQg2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

In This List

Pacira eyes expanded use of pain drug in children as trial meets safety goal

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

The Market Intelligence Platform


Pacira eyes expanded use of pain drug in children as trial meets safety goal

Pacira BioSciences Inc. plans to file for expanded approval of Exparel in the U.S. in 2020 after the non-opioid pain drug met the main goal of a late-stage study in children undergoing spinal or cardiac surgeries.

The phase 3 trial, dubbed Play, enrolled 98 patients who were divided into two groups. The first group consisted of patients aged 12 to less than 17 years while the second group consisted of children aged 6 to less than 12 years.

The Parsippany, N.J.-based pharmaceutical company said results from the study were consistent with the pharmacokinetic — study of the time course of drug absorption and metabolism — and safety profiles of Exparel as previously seen studies in adult patients.

Exparel is approved in the U.S. as a single-dose infiltration in adults for administration into the site of surgery for post-surgery pain relief and as a nerve block — a form of regional anesthesia injected into nerves before surgery — for regional pain relief. The company is also seeking EU approval of the drug.

Pacira said in a Dec. 17 press release that no safety concerns were seen in the patients at the 4 milligrams/kilogram dosage of the drug.

Pacira said that as per the U.S. Food and Drug Administration's guidance, the main objectives of the trial were to evaluate the pharmacokinetics and safety of the medicine in children.

The company noted that the results will help in filing a supplemental new drug application with the FDA in the first half of 2020.

Pacira noted that it expects to begin a second phase 3 registration study of Exparel, administered as a nerve block in children, in 2020.