clorazepate / Generic mfg. - LARVOL DELTA

What does data on adverse reactions reveal about benzodiazepines and suicide-related risk?: A disproportionality analysis using FDA FAERS pharmacovigilance data. (PubMed, Medicine (Baltimore)) - "After excluding 26 BZDs with insufficient psychiatric disorder-related AEs (<50 reports), 12 (diazepam, chlordiazepoxide, oxazepam, potassium clorazepate, lorazepam, bromazepam, clobazam, alprazolam, flurazepam, triazolam, temazepam, and midazolam) were retained for disproportionality analysis using zolpidem as a control. Adults <65 years who used potassium clorazepate, lorazepam, clobazam, alprazolam, or triazolam faced a significantly higher suicide-related risk than those ≥65 years. Compared to zolpidem, BZDs demonstrate varied suicide-related risks, which necessitated personalized risk-benefit evaluations and increased monitoring for high-risk agents such as flurazepam and alprazolam."

Adverse events • Journal • CNS Disorders • Mental Retardation • Psychiatry

Pharmacokinetics-driven individualized detoxification procedure in patients dependent on benzodiazepines and other GABA-A receptor modulators. (PubMed, Eur Addict Res) - "The SAER approach can minimize overaccumulation-related errors. The use of serum-BZD feedback curbs the initial overaccumulation. A forced concentration plateau establishes optimized initial conditions for the elimination process. By minimizing a superfluous high-concentration treatment phase, SAER provides more time for a careful escorting of the low-concentration crises, especially the one coinciding with elimination completion, weeks after drug discontinuation. Without extending the usual treatment time, the method aspires to improve both the reliability of the detoxification process and the treatment completion rate."

Journal • PK/PD data

Assessing pharmaceutical and illicit drugs abuse in a university environment through wastewater analysis. (PubMed, Sci Total Environ) - "The developed method provided limits of quantification ranging from 1.7 (LSD) to 73.1 (5-EAPB) ng L-1, recoveries from 81 (butylone) to 118 % (diphenhydramine), and relative standard deviations lower than 17 %...Venlafaxine and its main metabolite, escitalopram, and clorazepate were the pharmaceuticals found with the highest occurrence, with concentrations ranging from 15 (clorazepate) to 11,309 ng L-1 (O-desmethylvenlafaxine)...From these concentrations the population consumption was calculated, providing the highest mean consumption for venlafaxine and O-desmethylvenlafaxine (489.0 and 37.2 mg day-1 1000 people-1), followed by cocaine, tramadol, MDMA and amphetamine with consumption values of 40.8, 30.9, 30.8 and 17.0 mg day-1 1000 people-1, respectively. The proposed analytical strategy has been demonstrated to be suitable for monitoring the detection frequency of psychoactive substances, providing insight into temporal and..."

Journal

Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room (clinicaltrials.gov) - P3 | N=323 | Terminated | Sponsor: Assistance Publique - Hôpitaux de Paris | Trial completion date: Dec 2024 ➔ Apr 2024 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Apr 2024; It has been determined that continuing with enrollments in this study is no longer justified due to the lack of significant impact on the expected outcomes.

Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Migraine • Pain

Anti-seizure medications-associated bladder and urethral symptoms: a pharmacovigilance analysis based on the FAERS database. (PubMed, Expert Opin Drug Saf) - "In clinical practice, observations have been made regarding bladder and urethral symptoms (BUS), notably urinary frequency and urgency, among patients prescribed the anti-seizure medication (ASM) lacosamide...Several ASMs demonstrated statistically meaningful associations with BUS signals, notably ezogabine, valproic acid/valproate sodium, and clorazepate (p < 0.05)...Diazepam, gabapentin, and brivaracetam exhibited distinct risk profiles for severe BUS events compared to valproic acid/sodium valproate (p < 0.05)...This study yields valuable insights into the association between ASMs and BUS events, but several limitations warrant consideration. Nonetheless, these findings emphasize the significance of vigilance and proactive management of ASMs-associated BUS events."

Adverse events • Journal • CNS Disorders • Epilepsy

Severe alcohol withdrawal syndrome: review of the literature (EPA 2024) - "To alcohol consumption, the use of benzodiazepines such as lorazepam and bromazepam is occasionally added...Those with a long half-life (diazepam, clonazepam or dipotassium clorazepate) are preferable, since they avoid fluctuations in plasma levels, with better symptomatic control... Alcohol withdrawal syndrome is a clinically significant set of symptoms, behaviors, or physiological characteristics, varying in intensity and duration, that occur with cessation or reduction of alcohol consumption in people who have developed alcohol dependence or have consumed alcohol for a prolonged period or in large quantities. Autonomic hyperactivity, increased hand tremor, nausea, retching or vomiting, insomnia, anxiety, psychomotor agitation, transient visual, tactile or auditory hallucinations, and distractibility. Less commonly, the withdrawal state is complicated by seizures."

Review • Addiction (Opioid and Alcohol) • CNS Disorders • Epilepsy • Insomnia • Mood Disorders • Psychiatry • Psychomotor Agitation • Sleep Disorder

Extended Resolution of Severe Cervical Torsion Dystonia in Young Adult with DYT1 Dystonia and Chronic Deep Brain Stimulator (DBS) Implant After Single Injection of Botulinum Toxin (AAPMR 2023) - "Several medications were trialed with minimal benefit including baclofen, clorazepate, and trihexyphenidyl. Cervical dystonia refractory to DBS may be effectively treated with botulinum toxin in patients with DTY1 dystonia."

Clinical • CNS Disorders • Dystonia • Movement Disorders • Pain

Drugs for anxiety disorders. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Mood Disorders • Psychiatry

Effect of Clomethiazole Vs. Clorazepate on Hepatic Fat and Serum Transaminase Activities in Alcohol-Associated Liver Disease: Results from a Randomized, Controlled Phase II Clinical Trial. (PubMed, Alcohol Alcohol) - "This study demonstrates that CMZ improves clinical biomarkers for ALD in humans most likely due to its inhibitory effect on CYP2E1. Because of its addictive potential, CMZ can only be given for a short period of time and therefore other CYP2E1 inhibitors to treat ALD are needed."

Clinical • Journal • P2 data • Addiction (Opioid and Alcohol) • Hepatology • CYP2E1

Pharmacotherapy of alcohol withdrawal syndromes - Recommendations of the Polish Psychiatric Association and the Pharmacotherapy Section of the Polish Society for Addiction Research. (PubMed, Psychiatr Pol) - "The decision to choose a formulation should be based on its pharmacokinetic properties, comorbidities, and the patient's current condi�tion. The most commonly used BDZs are diazepam, lorazepam, oxazepam, and clorazepate."

Clinical guideline • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry

ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Clorazepate Dipotassium Tablets USP (Businesswire) - "ANI Pharmaceuticals, Inc...announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Clorazepate Dipotassium Tablets."

ANDA • CNS Disorders • Epilepsy

"$ANIP ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Clorazepate Dipotassium Tablets USP https://t.co/eMoV76rs3Q #fdaapproval" (@stock_titan)

FDA event

Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas (clinicaltrials.gov) - P4; N=100; Terminated; Sponsor: Polish Lymphoma Research Group; Recruiting ➔ Terminated; Slow recruitment

Clinical • HEOR • Trial termination • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Clorazepate Use for Alcohol Withdrawal in the Emergency Department (ASHP 2021) - No abstract available

Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room (clinicaltrials.gov) - P3; N=420; Recruiting; Sponsor: Assistance Publique - Hôpitaux de Paris; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Migraine • Pain

Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room (clinicaltrials.gov) - P3; N=420; Not yet recruiting; Sponsor: Assistance Publique - Hôpitaux de Paris; Initiation date: Mar 2021 ➔ Jul 2021

Clinical • Trial initiation date • CNS Disorders • Migraine • Pain

Benzodiazepine-Induced Photosensitivity Reactions: A Compilation of Cases from Literature Review with Naranjo Causality Assessment. (PubMed, Photodermatol Photoimmunol Photomed) - "Five benzodiazepines induced photosensitivity reactions. Five patients showed a definite association with the Naranjo scale. Reporting to pharmacovigilance databases may help identify other benzodiazepines causing photosensitivity reactions."

Clinical • Journal • Review • Allergy • Immunology

[VIRTUAL] Toothache (EPA 2021) - "In January 2019, she began mental health consultations with a diagnosis of adjustment disorder, on treatment with aripiprazole 5 mg/day, mirtazapine 15 mg/day, lorazepam 0.5 mg/day and dipotassium clorazepate 10 mg/day. After this intervention, the patient returns to accept oral intake.  Conclusions People with intellectual disabilities have a wide range of medical problems that in many cases are directly associated with the underlying disease or syndrome and, in others, with poor physical health due to problems in basic self-care skills or the ability to express verbally. Usually, the first manifestation of pain is an alteration in behaviour, which must be taken into account when making a differential diagnosis."

CNS Disorders • Mental Retardation • Pain

[VIRTUAL] Evaluation of Diazepam Nasal Spray in Patients with Epilepsy Concomitantly Using Maintenance Benzodiazepines: Interim Analysis from a Phase 3, Long-term, Open-label Safety Study (AAN 2021) - "This analysis evaluated diazepam nasal spray utilization and safety in patients with and without concomitant use of benzodiazepines, including alprazolam, clobazam, clonazepam, clorazepate, diazepam, lorazepam, and midazolam. In this long-term safety study, effects of diazepam nasal spray were similar whether or not patients used other benzodiazepines. In most cases, the number of doses used for seizure activity was independent of the presence of concomitant benzodiazepines, and no difference in retention rate was seen. Safety was consistent with what is expected for diazepam."

Clinical • P3 data • P3 data: top line • CNS Disorders • Epilepsy

Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room (clinicaltrials.gov) - P3; N=420; Not yet recruiting; Sponsor: Assistance Publique - Hôpitaux de Paris

Clinical • New P3 trial • CNS Disorders • Migraine • Pain