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Details:
Under the partnership, EVERSANA will support the expansion of its portfolio of pain and endocrinology products in the U.S., including Flector (diclofenac epolamine), a topical prescription therapy for acute pain due to minor strains, sprains, and contusions.
Lead Product(s): Diclofenac Epolamine
Therapeutic Area: Neurology Product Name: Flector
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Yaral Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership May 22, 2023
Details:
Diclofenac epolamine topical system 1.3% is a prescription nonsteroidal anti-inflammatory (NSAID) medicated patch indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.
Lead Product(s): Diclofenac Epolamine
Therapeutic Area: Neurology Product Name: Diclofenac Epolamine-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 January 03, 2023
Details:
Epoladerm™ (diclofenac epolamine), an investigational analgesic supplied in a pre-filled device for administration as a topical spray film to manage chronic pain associated with osteoarthritis of the knee.
Lead Product(s): Diclofenac Epolamine
Therapeutic Area: Musculoskeletal Product Name: Epoladerm
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kindeva Drug Delivery
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
Epoladerm (diclofenac epolamine), an investigational analgesic supplied in a pre-filled device for administration as a topical spray film to manage chronic pain associated with osteoarthritis of the knee.
Lead Product(s): Diclofenac Epolamine
Therapeutic Area: Musculoskeletal Product Name: Epoladerm
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Details:
Epoladerm (diclofenac epolamine) first-in-human study will be conducted in Q2 2022 and is supplied in a pre-filled device for administration as a topical spray film for treatment of chronic pain associated with osteoarthritis of the knee.
Lead Product(s): Diclofenac Epolamine
Therapeutic Area: Musculoskeletal Product Name: Epoladerm
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Virpax Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 21, 2022
Details:
Under the terms of this agreement, Charles River Laboratories will perform seven preclinical animal studies including method, dosage, and toxicity as part of the required the U.S. FDA enabling trials for an Investigational New Drug Application for Epoladerm.
Lead Product(s): Diclofenac Epolamine
Therapeutic Area: Musculoskeletal Product Name: Epoladerm
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Virpax Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 10, 2021
Details:
With the return of the commercial rights of Flector, a product that IBSA has developed, IBSA now offers two prescription topical drugs to treat acute pain due to minor strains, sprains, and contusions.
Lead Product(s): Diclofenac Epolamine
Therapeutic Area: Neurology Product Name: Flector
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: IBSA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 12, 2021
Details:
FDA agreed that it is reasonable for Virpax to pursue a 505(b)(2) New Drug Application (NDA) for Epoladerm™, which is an abbreviated approval pathway allowing Virpax to reference safety and efficacy data of a reference listed drug.
Lead Product(s): Diclofenac Epolamine
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2020
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