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baclofen (Gablofen)

✓ Approved

Piramal Critical Care · GABBR1 · Small Molecule

What is baclofen?

baclofen is a small molecule developed by Piramal Critical Care. It is approved for therapeutic indications via injectable (others) or intraspinal/intrathecal injection.

Drug Profile

Brand NamesGablofen
CompanyPiramal Critical Care
Drug ClassSmall Molecule
Molecular TargetGABBR1
RouteInjectable (Others), Intraspinal/Intrathecal Injection
StatusApproved
Sources: ClinicalTrials.gov, Piramal Critical Care

Mechanism of Action

Molecular Targets

baclofen acts on 1 molecular target:

GABBR1gamma-aminobutyric acid type B receptor subunit 1 (GABABR1, GB1)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

baclofen is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Nervous system disordersMuscle spasticity✓ Approved
Nervous system disordersComplex regional pain syndromePreclinical

Related Research Articles

PubMedAlcohol and alcoholism (Oxford, Oxfordshire)2026-07-21

Six approved drugs for alcohol use disorder: algorithms for their use according to the aims of treatment.

Caputo Fabio F, Vignoli Teo T, Lungaro Lisa L, Costanzini Anna A et al.

The pharmacological management of alcohol use disorder (AUD) currently includes six medications approved by different regulatory agencies worldwide: acamprosate (ACM), naltrexone (NTX), nalmefene (NMF), disulfiram (DF), baclofen, and sodium oxybate (SO). Their optimal use should be aligned with the main aims of treatment, namely reduction of alcohol consumption and maintenance of complete abstinence. This brief review summarizes the role of these six approved medications in AUD treatment and proposes practical treatment algorithms according to treatment goals, mechanisms of action, and clinically relevant outcomes. A focused narrative review of the literature was conducted, prioritizing meta-analyses, systematic reviews, randomized controlled trials, and relevant regulatory documents. Evidence on efficacy, safety, tolerability, and clinical applicability was interpreted pragmatically to support first-, second-, and third-line pharmacological strategies. For reducing alcohol intake, NMF or NTX are proposed as first-line pharmacotherapies, with baclofen considered as a second-line option when these agents are partially effective or ineffective. For maintaining abstinence, ACM is proposed as a first-line strategy. In selected clinical settings, including severe AUD, protracted alcohol withdrawal syndrome, high motivation for aversive treatment, or liver disease, SO, baclofen, DF, or NTX may serve as second-line options. Combined pharmacotherapy may be considered in highly adherent patients, whereas off-label drugs remain third-line options for refractory cases. Improved knowledge of the efficacy, safety, and tolerability of the six approved medications may support more appropriate, individualized, and goal-oriented pharmacological management of patients with AUD. The proposed algorithms are intended as pragmatic tools to aid clinical decision-making rather than as formal guidelines.

PMID 42476146
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PubMedBrain injury2026-07-19

Using intrathecal baclofen for effective management of paroxysmal sympathetic hyperactivity secondary to cerebral fat emboli syndrome: a case report.

Andary Michelle M, Bertagnolli Hannah H, Costeas Antonis A, Lamm Adam G AG

High energy impacts, such as motor vehicle accidents, may present with cooccurring long bone fractures and traumatic brain injuries. Cerebral fat emboli syndrome (FES) is one complication of long bone fractures which, in severe cases, may result in paroxysmal sympathetic hyperactivity (PSH). This case report presents a patient with treatment refractory PSH which persisted more than six months after initial injury when he first presented to an outpatient physiatry clinic. His clinical presentation at that time included spasticity, dystonia, diaphoresis, and tachycardia despite attempts at managing PSH with five different oral medications. An intrathecal baclofen trial was recommended which demonstrated significant improvement in PSH manifestations and an intrathecal pump was implanted as a result. Within three months following intrathecal baclofen pump placement, all oral medications for PSH were discontinued. To our knowledge, this is the first report of successful treatment of treatment refractory PSH secondary to cerebral fat emboli syndrome successfully treated with intrathecal baclofen. Early initiation of ITB in such instances can improve functional outcomes, decrease risk of polypharmacy, and reduce caregiver burden.

PMID 42471023
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PubMedRespiratory medicine case reports2026-07-19

Persistent hiccups following endobronchial ultrasound-guided transbronchial needle aspiration.

Saran Monika M, Kushwah Mithlesh M, Sindhwani Girish G, Panda Prasan Kumar PK

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive diagnostic procedure widely used in modern pulmonary medicine. Major complications are rare and usually hemorrhagic or infectious, while neurological sequelae are exceptionally uncommon. We report a rare case of persistent hiccups following EBUS-TBNA in a middle-aged man evaluated for fever and necrotic mediastinal lymphadenopathy with a probable diagnosis of tuberculosis or invasive fungal diseases. Despite extensive investigations, including cross-sectional imaging and upper gastrointestinal endoscopy, no structural abnormalities such as mediastinitis or pleuritis were identified. The patient's hiccups were severe, interfered with sleep, and persistent despite oral intake of baclofen for 5 days; however, resolved within 2 days of combination therapy with baclofen and chlorpromazine. This case highlights that hiccups, although uncommon, may occur as a direct and debilitating iatrogenic complication of EBUS-TBNA, likely due to mechanical stimulation of mediastinal neural structures. Clinicians should be aware of this potential complication, particularly when hiccups occur immediately after the procedure.

PMID 42471910
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PubMedJournal of microencapsulation2026-07-17

In vitro and in vivo investigation for nose to brain delivery of surface modified PLGA nanoparticles of baclofen.

Rai Garima G, Sharma Surbhi S, Devtalla Harshit H, Gauba Pammi P et al.

Baclofen is widely used for neuropathic pain but has limited therapeutic efficacy due to poor brain bioavailability and restricted penetration across the blood-brain barrier. To develop and evaluate polysorbate 80-coated PLGA nanoparticles for enhanced brain delivery of baclofen. Baclofen-loaded PLGA nanoparticles were prepared using the double emulsification solvent evaporation method and characterized for particle size, polydispersity index, zeta potential, entrapment efficiency, and drug loading. In vitro drug release, cytotoxicity, cellular uptake, and in vivo biodistribution studies were performed. The optimized nanoparticles showed a mean particle size of 141.2 nm, entrapment efficiency of 90.2%, and drug loading of 10.4%. Sustained drug release (79.42% over 48 h), minimal neuronal cytotoxicity, and enhanced cellular uptake were observed. In vivo biodistribution studies demonstrated significantly higher brain accumulation of baclofen compared with conventional delivery. Polysorbate 80-coated PLGA nanoparticles effectively enhanced baclofen brain delivery, providing sustained release, good biocompatibility, and improved brain targeting, indicating their potential for more effective neuropathic pain management.

PMID 42464757
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PubMedJournal of neurosurgery. Pediatrics2026-07-17

Intrathecal baclofen pump infection management: immediate versus delayed reimplantation. A single-center, 24-year experience.

McAbee Joseph H JH, O'Brien Patrick F PF, Teti Saige S, Magge Suresh N SN et al.

Intrathecal baclofen (ITB) pumps (ITBPs) are commonly used to provide symptomatic relief and facilitate patient care for children with spasticity. Unfortunately, patients are at long-term risk for device-related infections. Removal of infected pumps can require complicated, prolonged hospital stays for systematic reduction of preexisting high doses of ITB. The management strategy for ITBP infections has not been clearly defined. In this study, the authors sought to determine whether immediate reimplantation after wound washout is a viable strategy when managing ITBP infections rather than the more standard-of-care approach of removal and delayed reimplantation. A retrospective review was performed for patients who underwent ITBP placement at Children's National Hospital from 1999 to 2023 (24 years) with subsequent infection requiring removal and reimplantation. Demographics, timing of reimplantation, and outcomes were collected. Statistical analysis was performed with unpaired t-tests. Over 24 years, 356 baclofen pump implantation surgeries were performed with an overall infection rate of 9.8%. Seven patients underwent ITBP removal and delayed reimplantation, and 16 underwent washout with immediate reimplantation followed by extended intravenous antibiotic therapy. There was a statistically significant decrease/wean in ITB dose prior to surgery in the delayed group compared with the immediate reimplantation group (dose decreased by a mean of 209.1 vs 15.6 μg/day, p = 0.01) with a resultant increase in preoperative length of stay for baclofen weaning (2.57 vs 1.19 days), overall hospital stay (mean 13.14 vs 7.63 days), and postoperative baclofen withdrawal (42.9% vs 6.3%, p = 0.03). There was a significantly increased risk of reinfection in the immediate reimplantation cohort (63% vs 14%, p = 0.03). However, 33% of the patients with successful immediate reimplantation were able to maintain their current baclofen dose and did not require a prolonged ICU stay. Eighty percent of patients who experienced reinfection after immediate reimplantation chose final removal, while 86% of patients who underwent delayed reimplantation still have an existing ITBP. There is a lower risk of reinfection with removal and delayed reimplantation of ITBPs, and more patients in this cohort ultimately maintained their device. However, for patients on high ITB doses, immediate reimplantation in select cases may help to shorten hospital stays and prevent dangerous baclofen withdrawals and is successful for long-term pump utilization (without infection) one-third of the time.

PMID 42468045
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PubMedClinical practice and cases in emergency medicine2026-07-16

A Case Report of Delayed, Severe, Paroxysmal Muscle Cramping After Chilean Rose Tarantula (Grammostola rosea) Envenomation.

Gooley Brian B, Hughes Kirk K, Gooley Mark M, Keyler Daniel D et al.

Grammostola rosea (Chilean rose tarantula) is a common exotic pet belonging to the Theraphosidae (tarantula) family. Case reports of theraphosid bites in adults commonly describe local tissue damage and local pain. Muscle spasms have also been described as a result of the bites but are rarer. We present a case of severe and persistent muscle spasms after a G rosea bite, which is uncommonly reported in the literature. A 42-year-old woman was holding a G rosea tarantula when she was bit on the forearm. Within hours, severe local muscle cramping occurred. Due to worsening cramping, she initially presented to the emergency department the day after the bite, and again on the following day. She was admitted on her second visit and treated with diazepam, cephalexin, diphenhydramine, baclofen, cefpodoxime, doxycycline, prednisone, and topical hydrocortisone. Her laboratory testing was unremarkable, and while medical management may have mildly improved her symptoms, painful cramping persisted. After discharge, her paroxysmal muscle cramping continued for four weeks before completely resolving. While local tissue damage and pain are common, G rosea bites may lead to severe muscle cramping that persists for weeks. Standard laboratory testing may be completely normal in these cases. Muscle cramps may be persistent and are difficult to manage.

PMID 42456293
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