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Details:
The launch of Dr. Reddy’s Diclofenac Sodium Topical Gel, 1% (OTC), is an important addition to the Pain/ Analgesics portfolio of OTC products, and represents the continued commitment to the Private Label OTC space.
Lead Product(s): Diclofenac Sodium
Therapeutic Area: Rheumatology Product Name: Diclofenac Sodium-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2020
Details:
DARE-PDM1 is a novel delivery of the diclofenac sodium, a NSAID drug which inhibits COX-1 and COX-2 responsible for producing PGs which contributes in inflammation and pain signalling. It uses Daré’s proprietary hydrogel technology targeted at treating primary dysmenorrhea.
Lead Product(s): Diclofenac Sodium
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-PDM1
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2023
Details:
Because there are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea, DARE-PDM1 has the potential to be a first-in-category product.
Lead Product(s): Diclofenac Sodium
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-PDM1
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 12, 2022
Details:
Diclofenac topical solution is used to treat pain and swelling caused by osteoarthritis of the knees. Diclofenac Sodium Topical Solution, 2% w/w (RLD PENNSAID®) had estimated annual sales of USD 509 million in the U.S.
Lead Product(s): Diclofenac Sodium
Therapeutic Area: Musculoskeletal Product Name: Diclofenac Sodium-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2022
Details:
This phase 2/3 multi-center, randomized, double-blind trial investigated the effect of a new 3.06% diclofenac sodium gel formulation (AMZ001) for the relief of knee OA pain, in 444 patients exposed to either AMZ001 once daily (QD), AMZ001 twice daily (BID) or placebo.
Lead Product(s): Diclofenac Sodium
Therapeutic Area: Musculoskeletal Product Name: AMZ001
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 14, 2020