DURECT Corporation (NASDAQ:DRRX) shares were down 31.76% on Tuesday after its licensee received a letter from the US FDA.
DURECT Corporation (NASDAQ:DRRX) shares were down 31.76% to $1.16 and up 2.59% to $1.19 in after-hours trading. The company has a market cap of $155.73 million at 137.41 million shares outstanding. Share prices have been trading in a 52-week range of $0.99 to $2.70.
DURECT Corporation is a biopharmaceutical company with research and development programs. Its products candidates include DUR-928, oral for metabolic/lipid disorders, and DUR-928, injectable for acute organ injuries. Other product candidates are POSIMIR, which is a controlled release injection of bupivacaine, REMOXY, which is an oral controlled release oxycodone, ORADUR-ADHD, ELADUR, which is a controlled release injection of bupivicane, Relday, ORADUR-based opioid and SABER-based ophthalmic.
In a press release at the start of the week, DURECT Corporation announced that its licensee, Pain Therapeutics has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its New Drug Application for REMOXY ER extended-release capsules CII. Based on this review, however, the FDA noted that the application cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.
The CRL focuses on the abuse-deterrent properties of REMOXY ER and proposed drug labeling. The CRL makes no mention of clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior Complete Response Letter,” remarked DURECT Corporation licensee Pain Therapeutics.
Pain Therapeutics also went on to say that it is is evaluating the CRL and plan further discussions with the FDA. Also, the CRL noted that specific actions must be taken to prevent the three routes of abuse, something that may take approximately a year to conduct and may cost approximately $5 million for the company. DURECT is eligible to also receive royalties of between 6.0% to 11.5% of net sales if REMOXY ER is commercialized and may receive additional income from the sale of key excipients.
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