Zorvolex (diclofenac) / Assertio - LARVOL DELTA

Nonopioid drugs for pain. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Immunology • Neuralgia • Osteoarthritis • Pain • Rheumatology

Comparison table: Some nonopioid analgesics for pain. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Pain

FACT OA2: Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip (clinicaltrials.gov) - P3; N=1650; Completed; Sponsor: Regeneron Pharmaceuticals; Active, not recruiting ➔ Completed

Clinical • Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip (clinicaltrials.gov) - P2; N=23; Terminated; Sponsor: Regeneron Pharmaceuticals; N=50 ➔ 23; Trial completion date: Jun 2021 ➔ Aug 2020; Enrolling by invitation ➔ Terminated; Trial primary completion date: Jun 2021 ➔ Aug 2020; Lack of enrollment

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Immunology • Orthopedics • Osteoarthritis • Pain • Rheumatology

SoluMatrix® Diclofenac: Sustained Opioid-Sparing Effects in a Phase 3 Study in Patients with Postoperative Pain. (PubMed) - P3; "The opioid-sparing effect following low-dose SoluMatrix diclofenac (35 mg or 18 mg three times daily) administration was evaluated in patients experiencing pain following bunionectomy. Significantly fewer patients receiving SoluMatrix diclofenac or celecoxib (400 mg loading, 200 mg twice daily) required rescue medication during 0-24 h and >24-48 h following bunionectomy compared with placebo. No serious adverse events were reported among patients who received SoluMatrix diclofenac. SoluMatrix diclofenac may reduce opioid usage in the postoperative setting in patients with acute pain."

Journal • Biosimilar • Demo Pain • Pain

iCeutica receives key patent for SoluMatrix Fine Particle Technology platform (Businesswire) - "ICeutica Inc., today announced that its wholly owned subsidiary has been awarded a key patent for its SoluMatrix Fine Particle Technology™ platform by the U.S. Patent and Trademark Office (USPTO). The patent...covers the company’s dry milling method for producing submicron-sized particles that are 10 to 200 times smaller than conventional drug particles."

Patent • Pain

A phase 2 study evaluating the efficacy and safety of a novel, proprietary, nano-formulated, lower dose oral diclofenac (Pain Med) - P2, N=202; NCT00985439; Lower dose, nano-formulated diclofenac demonstrated good overall efficacy, prompt pain relief, and was well tolerated. These data suggest lower dose nano-formulated NSAIDs could be effective for acute pain and may potentially improve safety and tolerability as a result of using a lower overall dose

P2 data • Pain

Drug approval briefs: Cubist, Iroko, Merck Serono, UCB, Genentech, Allergan, GE Healthcare, Zogenix (Pink Sheet - Informa) - “Iroko Pharmaceuticals LLC’s small-particle diclofenac formulation Zorvolex won FDA approval for treatment of mild to moderate acute pain in adults...Zogenix Inc.’s Zohydro ER cleared FDA Oct. 25 for the management of pain...”

NDA • Pain

Low dose diclofenac (Zorvolex) for pain (Med Lett Drugs Ther) - Abstract not available.

Review • Pain

Iroko to present phase 3 data from submicron NSAID portfolio at American College of Rheumatology Annual Scientific Meeting (Businesswire) - "Iroko Pharmaceuticals...announced today that data from Phase 3 studies of Iroko’s investigational non-steroidal anti-inflammatory drugs (NSAIDs) submicron diclofenac and submicron indomethacin will be presented in poster sessions at the upcoming 2013 American College of Rheumatology (ACR) Annual Scientific Meeting, taking place in San Diego, from October 25-30."

Anticipated P3 data • Pain

Iroko Pharmaceuticals announces inclusion of Zorvolex in key 2015 national formularies (Businesswire) - "Iroko Pharmaceuticals...announced today that the company has secured favorable decisions from key Managed Care organizations for inclusion of ZORVOLEX® (diclofenac) capsules...on their 2015 National Formularies.'...The inclusion of ZORVOLEX ...that cover over 50 million commercial lives attest to the value ZORVOLEX can offer,' said John Vavricka, President and CEO of Iroko Pharmaceuticals."

Commercial • Pain

Effects of Food on Bioavailability of Analgesics; Resulting Dosage and Administration Recommendations. (PubMed, Pain Med) - "Overall, because food effects could alter the onset and/or duration of pain relief, analgesic medication should be used as per labeled recommendations for proper pain management."

Journal • CNS Disorders • Pain

Zyla Life Sciences reports third quarter 2019 financial results (PRNewswire) - "Zyla Life Sciences...today reported financial results for the third quarter ended September 30, 2019, including net sales from commercial products: SPRIX® (ketorolac tromethamine) Nasal Spray, the SoluMatrix® products, VIVLODEX® (meloxicam), TIVORBEX® (indomethacin) and ZORVOLEX® (diclofenac)), INDOCIN® (indomethacin) suppositories, INDOCIN® oral suspension and OXAYDO® (oxycodone HCI, USP) tablets for oral use only –CII....Net product sales were $22.4 million for the three months ended September 30, 2019 compared to $8.2 million for the three months ended September 30, 2018. The increase was largely due to the addition of the five acquired products at the end of January 2019."

Sales

Zyla Life Sciences to present at and participate in a panel at the 2019 Disruptive Growth Conference on September 5, 2019 (PRNewswire) - "Zyla Life Sciences...announced that Bob Radie, president and chief executive officer of Zyla, will give a corporate presentation and participate in a panel at the 2019 Disruptive Growth Conference....The presentation will include a review of Zyla's commercial products: SPRIX® (ketorolac tromethamine) Nasal Spray, the SoluMatrix® products, VIVLODEX® (meloxicam), TIVORBEX® (indomethacin) and ZORVOLEX® (diclofenac), INDOCIN® (indomethacin) suppositories, INDOCIN® oral suspension and OXAYDO® (oxycodone HCI, USP) tablets for oral use only –CII."

Clinical