Posimir (bupivacaine CR) / Durect - LARVOL DELTA

Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine (clinicaltrials.gov) - P4 | N=46 | Not yet recruiting | Sponsor: University of North Carolina, Chapel Hill

New P4 trial • Pain • Substance Abuse

"$DRRX Innocoll and DURECT Announce U.S. launch of POSIMIR® https://t.co/jVxcKkmxdX" (@stock_titan)

SABER-Bupivacaine Reduces Postoperative Pain and Opioid Consumption After Arthroscopic Subacromial Decompression: A Randomized, Placebo-Controlled Trial. (PubMed, J Am Acad Orthop Surg Glob Res Rev) - "Compared with placebo, SABER-Bupivacaine reduced pain and opioid analgesic consumption over 72 hours after arthroscopic subacromial decompression and prolonged the time to first use of opioid rescue analgesia. No safety signals were noted during the immediate postoperative period or at 6-month follow-up."

Journal • Orthopedics • Pain

Innocoll Announces Successful Completion of Debt Refinancing (Businesswire) - "Innocoll Biotherapeutics plc...announced today the successful refinancing of its existing term loan facility with a new $125 million term loan provided by funds managed by Oaktree Capital Management, L.P. ('Oaktree'). The new term loan meaningfully strengthens Innocoll’s financial flexibility and enables the Company to further invest in its R&D program and commercial organization for its innovative products....'By continuing to invest in our R&D and building our commercial organization, we are confident that we will position our innovative post-surgical, non-opioid pain products XARACOLL (bupivacaine hydrochloride implant) and POSIMIR® (bupivacaine solution) for long-term success.'"

Financing • Pain

PERSIST: Trial of Extended Release Bupivacaine for Pain Relief After Surgery (clinicaltrials.gov) - P3; N=399; Completed; Sponsor: Durect; N=296 ➔ 399

Clinical • Enrollment change • Pain

"$DRRX is going to EXPLODE this summer with imminent Posimir Partnership." (@TGTradingGroup)

Licensing / partnership

Durect stock soars 34% after it gets FDA approval for surgical pain treatment (Market Watch) - "Shares of Durect Corp....gained 34.3% in premarket trading on Tuesday after the company said its drug, Posimer, had been approved by the Food and Drug Administration as a treatment for pain after a certain type of shoulder surgery...Durect's stock is up 9.4% over the past year, while the S&P 500 SPX, 1.76% has gained 17.0%."

sNDA • Stock price • Pain

Efficacy of New Long-Acting Bupivacaine HTX-011 in Providing Pain Relief for Patients Undergoing Elective Surgery - A Meta-analysis of Prospective Randomized Controlled Trials. (PubMed, Anesth Essays Res) - "This is a combination of bupivacaine and meloxicam, and like its predecessors' liposomal bupivacaine and SABER bupivacaine, the combination slowly releases bupivacaine and provides therapeutic analgesic concentrations at the site of infiltration. Finally, the consumption of morphine was less by 10.61 (95% CI: 8.13-13.09) in 14 groups that reported such consumption. HTX-011 has a clear advantage in comparison to both placebo and bupivacaine and provides better pain relief and reduces opioid consumption."

Clinical • Journal • Retrospective data • Aesthetic Medicine • Anesthesia • Pain

DURECT Corporation Announces U.S. FDA Approval of POSIMIR For Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial Decompression (PRNewswire) - "DURECT Corporation...today announced that the U.S. Food and Drug Administration (FDA) has approved POSIMIR® (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression...The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff."

sNDA • Pain

"Me gustaría saber si las personas diabetica podría ponerse la vacuna eso me tiene preocupada." (@lugopinales1002)

"Si quieres ciencia, te la doy. Has leído el informe the @TheLancet donde nos ponen a caldo en manejo de la Pandemia? De VERDAD te interesa saberlo y leerlo? O es postureo? Si de verdad, DE VERDAD te interesa, dímelo. Igual estoy confundida y la ideología no guía tu vida." (@_Angua__)

"$ACV AIO, NCV, NCZ, CBH and ACV Declare Monthly Distributions https://t.co/SAbern6zjZ" (@otcdynamics)

"La coprecovid ya dijo que lo es cierto ... interesante saber quien maneja esa cuenta 🙄" (@quepurrrun)

"Depois que a Covid19 matou milhares de inocentes no mundo a OMS vai a China saber do vírus @DrTedros" (@ENIAQUINO)

Infectious Disease • Novel Coronavirus Disease

"Yes, the fearsome saber-fanged lapin was just....weird." (@DrSarcoma)

"Quisiera saber si es real que las personas con vih, hipertensión, enfermedades crónicas etc. no podremos vacunarnos?" (@Francis61787510)

SABER Study for Selected Early Stage Breast Cancer (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: University of Miami; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Q3 '11 results (Durect) - Posidur / Durect; Anticipated P3 data from BESST trial in Q4 '11; Anticipated NDA filing in H1 '12 depending on the positive data

Anticipated NDA filing • Anticipated P3 data • None • Pain

Durect Corporation announces fourth quarter 2012 financial results and update of programs (PRNewswire) - "'Communications with Pfizer indicate that they intend to meet with the FDA as planned in late March to discuss their proposed resubmission plan for REMOXY®'...We have multiple programs that may potentially be licensed over the next 12-18 months. These include POSIDUR, TRANSDUR-Sufentanil, ELADUR,..."

Anticipated FDA event • Anticipated licensing / partnership • Pain

Q2 2012 Results (Durect) - Anticipated NDA submission for pain in late 2012 or early 2013; Anticipated licensing in territories outside certain Asian and South Pacific markets in 2013 or 2014

Anticipated licensing / partnership • Anticipated NDA • Pain

"$DRRX Announces Amendment to Licensing Agreement with Sandoz Related to POSIMIR https://t.co/NndQCCSJOQ" (@BioStocks)

Biosimilar

Durect announces FDA acceptance of New Drug Application (NDA) submission for Posidur (SABER-bupivacaine) (Durect) - "DURECT...announced that the New Drug Application (NDA) for the investigational product POSIDUR (SABER-Bupivacaine) has been accepted by the U.S. Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review....The Prescription Drug User Fee Act (PDUFA) goal date...has been confirmed as February 12, 2014."

Anticipated PDUFA date • NDA • Pain

Durect Corporation invites you to join its first quarter 2012 earnings conference call (PRNewswire) - Durect Corporation to present first quarter 2012 financial results onThursday, May 3, 2012

Anticipated financial results • Pain

Durect announces top-line data from BESST (Posidur U.S. pivotal phase III trial) (PRNewswire) - P3, N=305; Results trended positive for both pain reduction and reduction of supplemental opioid use in first three days after surgery, they did not reach statistical significance; There were no signs of systemic safety issues, although local site reactions were observed more frequently in the Posidur and Saber-placebo groups than in the active comparator groups; A full safety assessment is not yet available; After a complete analysis of BESST data and preparation of integrated safety and efficacy reports combining previous well controlled studies,company intends to hold a pre-NDA meeting with the FDA

P3 data • Regulatory update • Pain

Durect receives back European product rights to Posidur (PRNewswire) - Durect reported that Takeda (through Nycomed) has given notice that it is returning its development and commercialization rights to Posidur in EU and their other licensed territories; Durect plans to work with partner Hospira to move the Posidur program forward in the U.S. and Canada and commence discussion with potential collaborators for other licensed territories; Durect currently is preparing integrated safety and efficacy reports for submission to FDA in conjunction with a pre-NDA meeting anticipated in mid-2012

Anticipated pre-NDA meeting • Collaboration agreement termination • Seeking partner • Pain