Recro Pharma shares tumble after FDA sends second response letter about pain killer meloxicam
Shares of Recro Pharma Inc (NASDAQ:REPH) dove Monday after the pharmaceutical company received a second complete response letter from the Food and Drug Administration about its new drug application for its intravenous drug meloxicam to treat moderate to severe pain.
The FDA’s comments in the letter note that IV meloxicam’s delayed onset fails to meet prescribers’ expectations for intravenous (IV) drugs. Regulators also have concerns over the use of meloxicam as a monotherapy for acute pain.
In response, Recro shares tumbled 37% to hit $6.05 in morning trade Monday.
The Malvern, Pennsylvania company said it “strongly disagrees” with the FDA’s interpretation and its views on the utility of IV meloxicam to address acute pain.
READ: Oppenheimer says Recro Pharma on track for approval of painkiller as overhang over stock eliminated
“We are extremely disappointed with the receipt of a second CRL from the FDA,” said Gerri Henwood, CEO of Recro Pharma in a statement. “We remain steadfast in our belief that IV meloxicam holds significant potential as a treatment option for moderate to severe pain in multiple clinical settings and remain committed to pursuing a path to regulatory approval.”
Recro will request a meeting with the FDA as it continues to seek the drug’s approval.
It received its first complete response letter in response to meloxicam last May. At the time, regulators said that data suggests the non-opioid pain killer’s analgesic effect fails to meet FDA expectations.
Recro Pharma is a specialty pharmaceutical company that operates via two businesses: an Acute Care hospital product division, and a revenue-generating contract development and manufacturing group in Gainesville, Georgia.
Contact Ellen Kelleher at [email protected]
Story by ProactiveInvestors
Source: https://www.proactiveinvestors.com/companies/news/217152/recro-pharma-shares-tumble-after-fda-sends-second-response-letter-about-pain-killer-meloxicam-217152.html
Anyone can join.
Anyone can contribute.
Anyone can become informed about their world.
"United We Stand" Click Here To Create Your Personal Citizen Journalist Account Today, Be Sure To Invite Your Friends.
Please Help Support BeforeitsNews by trying our Natural Health Products below!
Order by Phone at 888-809-8385 or online at https://mitocopper.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomic.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomics.com M - F 9am to 5pm EST
Humic & Fulvic Trace Minerals Complex - Nature's most important supplement! Vivid Dreams again!
HNEX HydroNano EXtracellular Water - Improve immune system health and reduce inflammation.
Ultimate Clinical Potency Curcumin - Natural pain relief, reduce inflammation and so much more.
MitoCopper - Bioavailable Copper destroys pathogens and gives you more energy. (See Blood Video)
Oxy Powder - Natural Colon Cleanser! Cleans out toxic buildup with oxygen!
Nascent Iodine - Promotes detoxification, mental focus and thyroid health.
Smart Meter Cover - Reduces Smart Meter radiation by 96%! (See Video).