Last reviewed 2026-04-20 · How we verify

Intrathecal

Intrathecal, marketed by Lena Nilsson, holds a niche position in the pharmaceutical market with its unique intrathecal administration route. The key composition patent, set to expire in 2028, provides a significant barrier to entry for potential generic competitors. The primary risk lies in the lack of clear revenue data and key trial results, which may affect investor confidence and market adoption.

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and car

Common side effects

• Somnolence
• Dizziness
• Nausea
• Hypotension
• Headache
• Convulsions
• Hypotonia
• Paresthesia
• Vomiting
• Dyspnea
• Abnormal gait
• Tremor

Serious adverse events

• Coma (secondary to overdose)
• Meningitis
• Pump pocket infections
• Wound dehiscence
• Pump overpressurization
• Cerebrovascular accident
• Cerebral ischemia
• Psychotic depression
• Gynecological fibroids

Key clinical trials

• Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
• Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain
• A Study of Deferoxamine (DFO) in People With Leptomeningeal Metastasis (PHASE1)
• A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia (PHASE1)
• IT-TT as an Effective and Well-Tolerated Strategy for CNS Prop in High-Risk DLBCL: a Prospective Ph II Study (PHASE2)
• Analgesic Effects of Intrathecal Morphine and Transversalis Plane Block After Cesarean Delivery
• Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC (PHASE2)
• Comparison of Intrathecal Morphine and Rectus Sheath Block for Postoperative Pain Management After Lower Abdominal Surgery With Midline Incision (NA)

Primary sources

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