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Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Scilex Holding Company, a Majority-Owned Subsidiary of Sorrento Therapeutics, Inc., to Present SP-102 (SEMDEXA) Efficacy and Safety Data from its Pivotal Phase 3 Clinical Trial Program for Sciatica Pain Management at the 24th Annual Meeting of American So","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Scilex, a Sorrento Company, Announces Pivotal Phase 3 SP-102 (SEMDEXA) Data Presentation At The American Society Of Interventional Pain (ASIPP) 2022 Annual Meeting","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase 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For the Right to Commercialize Gloperba, an FDA-Approved Prophylactic Treatment for Painful Gout Flares in Adults, in the US","therapeuticArea":"Rheumatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Rheumatology","graph2":"Approved"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Scilex Holding Company, a Sorrento Company, Announces Continued Growth in ZTlido in Managed Health Care Plans","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"CH Trading Group","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Scilex Holding Company, a Sorrento Company, Announces Exclusive Product Distribution Agreement with CH Trading Group LLC to Expand Commercialization of ZTlido\u00ae Across Certain Designated Territories Including Middle East and North Africa","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Scilex Holding Company, a Sorrento Company, Announces That the FDA Has Granted Fast Track Designation for SP-103 (Lidocaine Topical System) 5.4%, Next Generation Triple Strength Formulation of ZTlido\u00ae, for the Treatment of Acute Low Back Pain (LBP)","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Scilex Holding Company Announces the Commercial Launch Of ELYXYBTM (celecoxib oral solution) in the U.S., Strengthening Its Leadership Position in Non-Opioid Pain Management","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"YA II PN","pharmaFlowCategory":"D","amount":"$25.0 million","upfrontCash":"Undisclosed","newsHeadline":"Scilex Holding Company Announces Financing of up to $25 Million to Enhance Commercialization of Three FDA Approved Non-Opioid Pain Management Products","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Scilex Holding Company Announces Complete Enrollment of a Phase 2 Study to Evaluate the Safety and Efficacy of SP-103 (lidocaine topical system) 5.4%, Triple Strength Formulation of ZTlido\u00ae, for the Treatment of Acute Low Back Pain","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Farouk, Maamoun Tamer & Co.","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Scilex Holding Company Enters Master Distributor Agreement Among CH Trading Group LLC (\u201cCHT\u201d or \u201cTerritories Distributor\u201d) and Farouk, Maamoun Tamer & Co. (\u201cMaster Distributor\u201d) For the Distribution of ZTlido\u00ae in the Kingdom of Saudi Arabia","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Scilex Holding Company Announces Positive Type C Meeting with the FDA and Reaches Agreement on Path Forward to File an NDA for SP-102 (SEMDEXATM) in Lumbosacral Radicular Pain (Sciatica)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Scilex Holding Company Announces Seeking Approval from the FDA for Modification of the Gloperba\u00ae Label to Provide Specific Dosing Guidance for Patients with Renal Impairment and Other Circumstances Where Dose Adjustment is Needed","therapeuticArea":"Rheumatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Rheumatology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Scilex Pharmaceuticals
Gloperba (colchicine) liquid oral solution is a USFDA approved, tubulin inhibitor small molecule drug candidate which is indicated for prophylaxis of gout flares in adults.
SP-102 (semdexatm) is expected to be administered in up to 3 injections during a 6-month observation period. Completion of enrollment for Lumbosacral Radicular Pain (Sciatica) in the trial is projected to occur in 2025.
The agreement aims for the distribution of Ztlido (lidocaine), a lidocaine topical system approved for the relief of neuropathic pain associated with post-herpetic neuralgia, in Kingdom of Saudi Arabia.
SP-103 (lidocaine topical system) 5.4% triple strength formulation for ZTlido®, is being investigated in subjects with moderate to severe acute lower back pain (LBP).
Proceeds from the financing commitment will be used to enhance the launch and commercialization of Scilex’s three FDA-approved non-opioid pain management products, ZTlido (lidocaine), Gloperba (colchicine) and Elyxyb (celecoxib), for the treatment of acute and chronic pain.
Elyxyb (celecoxib) is a nonsteroidal anti-inflammatory drug with analgesic, anti-inflammatory, and antipyretic properties. Celecoxib inhibits prostaglandin synthesis, primarily via inhibition of COX-2. It is being developed for migrane pain.
SP-103 has three times the drug load of ZTlido® (Lidocaine - 108 mg versus 36 mg) in the same adhesive system to potentially deliver a three-fold level of the drug within a targeted area, but retaining the convenience of a single topical system.
ZTlido® (lidocaine topical system) 1.8%, or ZTlido®, is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain.
Gloperba is the first liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults and was made available in the United States in 2020.
ZTlido® (lidocaine topical system) 1.8%, a best-in-class prescription lidocaine topical product used for relief of pain from damaged nerves (neuropathic pain) that follows healing of shingles.