This section highlights FDA-related milestones and regulatory updates for drugs developed by Sorrento Therapeutics (SRNE).
Over the past two years, Sorrento Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SP-102 and ZTlido. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SP-102 (SEMDEXA) - FDA Regulatory Timeline and Events
SP-102 (SEMDEXA) is a drug developed by Sorrento Therapeutics for the following indication: Sciatica Pain Management.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SP-102 (SEMDEXA)
- Announced Date:
- May 1, 2025
- Indication:
- Sciatica Pain Management
Announcement
Scilex Holding Company announced an upcoming presentation of post-hoc analysis of the C.L.E.A.R. trial (Corticosteroid Lumbar Epidural Analgesia in Radiculopathy) interpreting clinical meaningfulness of safety and efficacy of SP-102 (SEMDEXA™) for the treatment of lumbosacral radicular pain (LRP) at the 27th Annual Meeting of American Society of Interventional Pain Physicians (ASIPP), May 15-17, 2025 in Orlando, FL.
AI Summary
Scilex Holding Company has announced that it will present a post-hoc analysis of the C.L.E.A.R. trial at the 27th Annual Meeting of the American Society of Interventional Pain Physicians in Orlando, FL, from May 15 to 17, 2025. This analysis examines the clinical meaningfulness of both the safety and efficacy of SP-102 (SEMDEXA™) for treating lumbosacral radicular pain, a common cause of sciatica. The presentation will detail how the data supports SP-102 as a promising non-opioid option for patients suffering from this type of pain. In addition to the live display at the meeting, the poster will be accessible through the conference app and later published in the Pain Physician journal, making it widely available to clinicians and researchers interested in innovative pain management solutions.
Read Announcement- Drug:
- SP-102 (SEMDEXA)
- Announced Date:
- June 14, 2024
- Indication:
- Sciatica Pain Management
Announcement
Scilex Holding Company announced the publication of results of the pivotal registration trial of SP-102 (SEMDEXA™) in PAIN, the official journal of the International Association for the Study of Pain, which features original research on the nature, mechanisms and treatment of pain.
AI Summary
Scilex Holding Company announced that the results of its pivotal Phase 3 registration trial for SP-102 (SEMDEXA™) have been published in PAIN®, the official journal of the International Association for the Study of Pain. This journal is known for featuring influential research on the nature, mechanisms, and treatment of pain. The trial tested SP-102 in patients suffering from sciatica due to lumbosacral radicular pain, enrolling 401 subjects with moderate to severe leg pain from intervertebral lumbar disc herniation.
The study met its primary and key secondary endpoints by showing a statistically significant and clinically meaningful reduction in pain intensity for over a month, along with improvements in disability scores. Additionally, the safety profile of SP-102 was similar to that of the placebo, further supporting its potential to become a new treatment option for sciatica.
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ZTlido - FDA Regulatory Timeline and Events
ZTlido is a drug developed by Sorrento Therapeutics for the following indication: Alleviate pain associated with post-herpetic neuralgia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZTlido
- Announced Date:
- August 30, 2024
- Indication:
- Alleviate pain associated with post-herpetic neuralgia
Announcement
Scilex Holding Company announced oral, poster presentations, and symposia on ZTlido (lidocaine topical system) at the 2024 Annual PAINWeek conference in Las Vegas, NV on September 3-5, 2024.
AI Summary
Scilex Holding Company announced that it will showcase new data on its product ZTlido (lidocaine topical system) at the 2024 Annual PAINWeek conference in Las Vegas, NV from September 3-5, 2024. The company has planned a series of oral presentations, poster sessions, and symposia focused on the latest clinical insights for ZTlido. During these sessions, industry experts will discuss how ZTlido may offer alternative pain management options, especially for patients who face challenges with other medications like gabapentinoids. One notable presentation on September 4 will feature Dr. Charles Argoff, who will review how ZTlido might be integrated into treatment regimens. Additional sessions on September 5 will present analyses comparing decreased opioid and cost utilization between ZTlido 1.8% and a 5% patch formulation. These events provide a key platform for healthcare professionals to explore advances in non-opioid pain management.
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