Monday, October 31, 2011 1:32:24 PM
By Ryan McBride
Pacira Pharmaceuticals ($PCRX) has gained its first big FDA green light for a drug since wrapping a small IPO in February. U.S. regulators approved the company's long-acting bupivacaine product, Exparel, for treating pain after surgeries, the company said this morning.
The company's stock was up just shy of 2% as of 12:30 pm ET today, after the price had surged considerably and then settled down in pre-market trading this morning.
The FDA approval of the Parsippany, NJ-based developer's drug came after a series of successful clinical trials, including a pivotal study in which it was used to treat pain in patients who underwent surgeries to remove hemorrhoids. That study showed that the one dose of the long-acting drug, which is injected at the surgical site, provided significant drops in pain and opioid use for up to 72 hours after the surgeries.
Typically, the product's active ingredient alone, bupivacaine, lasts only about 7 hours when injected after surgeries and then clinicians have to turn to opioids and other remedies to control post-surgical pain, according to the company.
"Traditional opioid medications, while effective at providing pain relief, have a long list of unwanted side effects," Dr. Sonia Ramamoorthy, associate professor of surgery at the University of California, San Diego, said in Pacira's release. "Exparel, a single dose administration, non-opioid therapy, has the potential to reduce or delay the use of opioids following inpatient and outpatient surgical procedures."
With expected sales of Exparel, Pacira can now bank on revenue from a third marketed product and deliver a key victory to investors who supported the firm's initial public offering back in February. While the difficulty of the market for public debuts in biotech forced the company to significantly reduce its IPO price from a desired $14 to $16 per share down to $7 per share, now those backers who had faith in the company will be rewarded. Exparel is expected to be the No. 1 product for Pacira, which also gets revenue from two marketed products that use its drug-delivery technology. Still, new drug launches have been difficult as of late and are not always home runs for developers.
"This FDA approval is an important milestone for Pacira, as well as the millions of patients undergoing surgical procedures in the U.S. each year," Dave Stack, the company's CEO, said in a statement. "We are excited to launch Exparel in the United States."
SOURCE: FIERCEBIOTECH
Recent PCRX News
- Pacira BioSciences to Participate in Fireside Chat at the 2024 RBC Capital Markets Global Healthcare Conference • GlobeNewswire Inc. • 05/07/2024 12:00:00 PM
- Pacira to Report First Quarter 2024 Financial Results on Tuesday May 7, 2024 • GlobeNewswire Inc. • 04/30/2024 12:00:00 PM
- Pacira BioSciences to Participate in Fireside Chat at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 04/02/2024 12:00:00 PM
- Pacira BioSciences Announces PCRX-201 Granted Regenerative Medicine Advance Therapy (RMAT) Designation for the Treatment of Osteoarthritis of the Knee • GlobeNewswire Inc. • 03/13/2024 11:00:00 AM
- Pacira BioSciences to Participate in Fireside Chat at the Barclays 26th Annual Global Healthcare Conference • GlobeNewswire Inc. • 03/06/2024 01:00:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 08:33:13 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/29/2024 01:03:32 PM
- Pacira BioSciences Reports Fourth Quarter and Full-Year 2023 Financial Results • GlobeNewswire Inc. • 02/29/2024 01:00:00 PM
- Pacira to Report 2023 Financial Results on Thursday February 29, 2024 • GlobeNewswire Inc. • 02/22/2024 01:00:00 PM
- Pacira Announces Publication of Pivotal Study of EXPAREL as a Sciatic Nerve Block in the Popliteal Fossa for Patients After Bunionectomy • GlobeNewswire Inc. • 02/15/2024 01:36:16 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:59:39 PM
- Pacira BioSciences Awarded Brand Pharmaceuticals Agreement With Premier, Inc. • GlobeNewswire Inc. • 02/07/2024 01:00:00 PM
- G.O.A.T. Bowl I Registration Open to 4 Additional Pickleball Teams • PR Newswire (US) • 02/01/2024 03:45:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:25:59 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:24:39 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:21:34 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:18:43 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/04/2024 10:02:42 PM
- Pacira Reports Preliminary Unaudited Fourth Quarter and Full-Year 2023 Revenues • GlobeNewswire Inc. • 01/04/2024 10:00:41 PM
- Pacira BioSciences to Present at the 42nd Annual J.P. Morgan Healthcare Conference • GlobeNewswire Inc. • 01/03/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/21/2023 12:33:59 PM
- Pacira Appoints Frank D. Lee as Chief Executive Officer • GlobeNewswire Inc. • 12/21/2023 12:30:00 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 12/08/2023 12:44:29 AM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 11/13/2023 02:41:16 PM
- Pacira Announces FDA Approval of Expanded EXPAREL Label to Include Two Additional Nerve Block Indications • GlobeNewswire Inc. • 11/10/2023 12:30:00 PM
FEATURED Cannabix Technologies Launches New Compact Breath Logix Workplace Series and Prepares for Delivery to South Africa • May 7, 2024 8:51 AM
Moon Equity Holdings, Corp. Announces Acquisition of Wikolo, Inc. • MONI • May 7, 2024 9:48 AM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM