PHOENIX, July 27, 2018 (GLOBE NEWSWIRE) — INSYS Therapeutics, Inc. (NASDAQ: INSY) announced that today it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) for a buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain.
Consistent with the outcome of an FDA Advisory Committee meeting in May, the CRL indicates that, although the clinical development program demonstrated all three proposed doses of the product candidate were statistically significantly different than placebo in providing pain relief, some of the data suggested potential safety concerns.
“Given the attributes of our proprietary buprenorphine formulation for sublingual delivery, we continue to believe that this drug-device combination could bring value to the management of pain and will assess the next steps in the context of the company’s overall mission,” said Steve Sherman, senior vice president of regulatory affairs for INSYS Therapeutics.
INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with a significant unmet need.
This news release contains forward-looking statements based on management’s expectations and assumptions as of the date of this news release. Actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended Dec. 31, 2017 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.
INSYS Therapeutics, Inc.
Posted: July 2018
- INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray – May 22, 2018
- FDA Accepts New Drug Application (NDA) for Buprenorphine Sublingual Spray from INSYS Therapeutics – December 6, 2017
- INSYS Therapeutics Files New Drug Application (NDA) for Buprenorphine Sublingual Spray with FDA – September 29, 2017
buprenorphine FDA Approval History
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