DURECT CORPORATION (NASDAQ:DRRX) Files An 8-K Other Events

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DURECT CORPORATION (NASDAQ:DRRX) Files An 8-K Other Events

DURECT CORPORATION (NASDAQ:DRRX) Files An 8-K Other Events
Item 8.01 Other Events

On July 30, 2018, DURECT Corporation issued a press release announcing that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for PERSERIS™ (risperidone), which was formerly known as RBP-7000. As described by Indivior, PERSERIS is the first once-monthly subcutaneous risperidone-containing, long-acting injectable for the treatment of schizophrenia in adults. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.

Item 8.01 Financial Statements and Exhibits

(d) Exhibits

99.1

Press Release of DURECT Corporation dated July 30, 2018


DURECT CORP Exhibit
EX-99.1 2 drrx-ex991_6.htm EX-99.1 drrx-ex991_6.htm   Exhibit 99.1   DURECT Announces FDA Approval of Indivior’s PERSERIS™ (risperidone)  Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults   Approval triggers $5 million milestone payment to DURECT and future earn-out payments based on U.S. net sales       CUPERTINO,…
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About DURECT CORPORATION (NASDAQ:DRRX)

Durect Corporation is a biopharmaceutical company with research and development programs. The Company’s products candidates include DUR-928, oral for metabolic/lipid disorders, and DUR-928, injectable for acute organ injuries. Its other product candidates include POSIMIR (controlled release injection of bupivacaine), REMOXY (oral controlled release oxycodone), ORADUR-ADHD, ELADUR (controlled release injection of bupivicane), Relday (risperidone), ORADUR-based opioid (hydromorphone) and SABER-based ophthalmic. The Company’s ALZET product line consists of miniature, implantable osmotic pumps and accessories used for experimental research in mice, rats and other laboratory animals. The Company also manufactures and sells osmotic pumps used in laboratory research and design; and develops and manufactures a range of standard and custom biodegradable polymers and excipients for pharmaceutical and medical device clients for use as raw materials in their products.