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Lead Product(s): Tanezumab
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2020
Details:
The tanezumab regulatory submission encompasses data from 39 Phase 1-3 clinical studies evaluating the safety and efficacy of tanezumab among more than 18,000 patients.
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Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: INP104
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2020
Details:
Within two hours of receiving their first dose of INP104, 38% of all patients reported freedom from migraine pain, 52% had freedom from their most bothersome migraine symptom (MBS) and 66.3% experienced pain relief.
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Lead Product(s): SP-102
Therapeutic Area: Neurology Product Name: Semdexa
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2020
Details:
Scilex’s SP-102 (SEMDEXA™) is currently being evaluated in a pivotal Phase 3 clinical trial in the U.S. to evaluate patients with lumbosacral radicular pain/sciatica. SP-102 could potentially be the first FDA approved epidural steroid product for the treatment of sciatica.
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Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Product Name: Qtrypta
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2020
Details:
The DRL described two concerns regarding clinical pharmacology section of the NDA; (i) regarding unexpected high plasma concentrations of zolmitriptan observed from two pharmacokinetic studies; (ii) the FDA raised questions regarding differences in zolmitriptan exposures.
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Lead Product(s): Resiniferatoxin
Therapeutic Area: Neurology Product Name: RTX
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2020
Details:
The Phase 1b trial was a placebo controlled ascending dose study with an open-label extension to assess the safety and preliminary efficacy of intra-articular administration of RTX or saline control for moderate to severe pain due to osteoarthritis of the knee.
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Lead Product(s): Diazepam
Therapeutic Area: Neurology Product Name: Libervant
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2020
Details:
U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for management of seizure clusters.
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Lead Product(s): Ganaxolone
Therapeutic Area: Neurology Product Name: CCD 1042
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2020
Details:
Marinus Pharmaceuticals has satisfied the FDA’s protocol-specific questions for the registrational Phase 3 trial (the RAISE trial) in refractory status epilepticus (RSE), allowing the company to begin enrollment in this clinical trial.
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Lead Product(s): Meloxicam,Rizatriptan Benzoate
Therapeutic Area: Neurology Product Name: AXS-07
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2020
Details:
AXS-07, the Company’s novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine, rapidly relieved and substantially reduced relapse of migraine pain, as compared to the potent active comparator rizatriptan, in the MOMENTUM Phase 3 trial.
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Lead Product(s): Meloxicam,Rizatriptan Benzoate
Therapeutic Area: Neurology Product Name: AXS-07
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2020
Details:
The results of the Phase 3 MOMENTUM trial were one of the 12 selected abstracts. The Phase 3 Momentum Trial evaluated efficacy and safety of AXS-07 for the acute treatment of migraine.
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Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2020
Details:
More than 90% of patients receiving HTX-011, along with postoperative over-the-counter acetaminophen and ibuprofen, remained opioid-free throughout the 72-hour period following hernia repair surgery.
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