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Author: Grafiati
Published: 10 March 2023

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1

Berbenni, Vittorio, Amedeo Marini, Gianna Bruni, Marcella Bini, Angelo Magnone-Grato, and Marco Villa. "Spectroscopic and Thermoanalytical Characterization of (+)-Fenfluramine Hydrochloride." Applied Spectroscopy 50, no. 7 (July 1996): 871–79. http://dx.doi.org/10.1366/0003702963905439.

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We have analyzed the vibrational, structural, and thermal properties of a pure enantiomer of fenfluramine. At room temperature the samples, as-received or ground, are in the α-phase, in which hydrogen bonds are formed among adjacent molecules. Evidence of these H bonds is no longer found in samples which have been annealed above a critical temperature. Grain size, sample treatment, or defects influence the temperature range where the H bonds break down; this phenomenon is accompanied by thermal effects such as endothermic peaks or anomalies of heat capacity, and followed by a slow structural rearrangement into a γ-phase. No evidence of hydrogen bonds is found in the water recrystallized fenfluramine, which maintains up to the melting temperature a crystallographic form (β-form) distinct from both α - and γ-phases. It is suggested that “folded” and “extended” fenfluramine molecules are characteristic of the α- and β-phase, respectively.
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2

Shapira, Baruch, Bernard Lerer, Seth Kindler, Pesach Lichtenberg, Cornelius Gropp, Thomas Cooper, and Avraham Calev. "Enhanced Serotonergic Responsivity Following Electroconvulsive Therapy in Patients with Major Depression." British Journal of Psychiatry 160, no. 2 (February 1992): 223–29. http://dx.doi.org/10.1192/bjp.160.2.223.

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Prolactin release in response to fenfluramine hydrochloride (60 mg orally) and placebo was evaluated in 18 medication-free patients with RDC major depressive disorder, endogenous subtype, before and after a series of bilateral treatments with ECT. Before ECT, fenfluramine induced a twofold increase in plasma prolactin levels. This response was significantly enhanced after the ECT series, while baseline prolactin levels and response to the placebo challenge were not altered. There was no significant difference in plasma fenfluramine and norfenfluramine levels during the pre- and post-ECT challenges. These findings suggest that ECT enhances central serotonergic responsivity and extend to depressed patients pre-clinical observations regarding the effect of electroconvulsive shock on serotonergic function.
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3

Dozières-Puyravel, Blandine, and Stéphane Auvin. "Fenfluramine hydrochloride for the treatment of Dravet syndrome." Expert Opinion on Orphan Drugs 8, no. 4 (April 2, 2020): 121–26. http://dx.doi.org/10.1080/21678707.2020.1758930.

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4

Stefaniak, Martyna, Zofia Pietrzak, Piotr Dzikowski, Emilia Nowicka, Michał Obel, and Halina Piecewicz-Szczęsna. "Efficacy and safety of fenfluramine in the treatment of Dravet syndrome - literature review." Journal of Education, Health and Sport 12, no. 1 (January 14, 2022): 106–16. http://dx.doi.org/10.12775/jehs.2022.12.01.008.

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Dravet Syndrome is a severe, drug-resistant, and rare epileptiform disorder that is typically presented in the first year of life in an otherwise healthy child. It is characterized by prolonged seizures that are often resistant to current anti-epileptic drug regimens, which made them poorly controlled, and almost 50% of patients experience at least four tonic-clonic seizures per month. There are three new medicines: stiripentol, cannabidiol, and fenfluramine, with documented efficacy and safety as adjunctive therapies in pharmacoresistant Dravet syndrome treatment. This study aimed to assess the efficacy and safety of fenfluramine in the treatment of Dravet syndrome. Our study material consisted of publications, which were found in PubMed, Google Scholar, and Embase databases. In order to find the proper publications, the search has been conducted with the use of a combination of keywords like: “fenfluramine”, “Dravet syndrome”, “epilepsy treatment”, “Dravet syndrome pediatric patients”. The first step was to find proper publications from the last 10 years. The second step was to carry out an overview of the found publications. Results of mentioned studies proved that in Dravet syndrome, fenfluramine provided a significantly greater reduction in convulsive seizure frequency compared with placebo. No patient developed valvular heart disease or pulmonary arterial hypertension, the side effects that occurred during its use were mild and the drug was generally well-tolerated. The bioequivalence and tolerability of single oral doses of fenfluramine hydrochloride oral solution in the fed and fasted states support drug administration without regard to meals. Fenfluramine may represent a new important treatment option for Dravet syndrome.
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5

Lerer, Bernard, Dan Gillon, Pesach Lichtenberg, Malka Gorfine, Yevgenia Gelfin, and Baruch Shapira. "Interrelationship of Age, Depression, and Central Serotonergic Function: Evidence From Fenfluramine Challenge Studies." International Psychogeriatrics 8, no. 1 (March 1996): 83–102. http://dx.doi.org/10.1017/s1041610296002499.

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The purpose of this study was to examine the relationship between age-associated changes in central serotonergic function and abnormalities associated with major depression. Under randomized double-blind conditions, prolactin and cortisol responses to the serotonin-releasing agent d,l-fenfluramine hydrochloride (60 mg orally) and placebo were examined in 30 normal subjects (15 men, 15 women; age range 21–84 years) and 39 patients with major depressive disorder, endogenous subtype (14 men, 25 women; age range 29–72 years). In the normal subjects, a significant Age x Challenge x Time interaction was observed in the prolactin response (p = .03). This was primarily due to the elevated prolactin responses of the younger healthy women. Peak minus baseline (delta) prolactin responses were negatively correlated with age (women, p = .004; men, p = .06). In the depressed patients there was no age-related decline in prolactin response to fenfluramine. When depressed and healthy younger subjects were compared, delta prolactin responses to fenfluramine were significantly blunted in young patients with depression (p = .003) irrespective of the significant effect of gender (p = .01), but not in older depressed patients. Cortisol responses to fenfluramine did not reveal consistent effects of age, gender, or diagnosis. Age-related decline in central serotonergic function may make older individuals more vulnerable to depression and possibly render depressive episodes more frequent, more severe, and less amenable to treatment.
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6

Balabolkin, M. I., and O. M. O.M. Novikov. "Mechanisms of the effects of fenfluramine on type II diabetes mellitus in combination with obesity." Problems of Endocrinology 42, no. 1 (February 15, 1996): 11–14. http://dx.doi.org/10.14341/probl11898.

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With obesity-related diabetes, it is possible to use biguanides, which have a slight anorectic effect. The presence of side effects in biguanides often complicates their long-term use, especially in elderly patients who have a history of chronic diseases of the lungs, heart, kidneys, and liver. In such cases, it is advisable to prescribe anorectic drugs that simultaneously affect carbohydrate metabolism.One of these drugs is p-ethyl-a-methyl-3-fluoromethylphenethylamine hydrochloride (minifage, ponderal), which has a stimulating effect on the central nervous system. Fenfluramine reduces the supply and synthesis of monoamines (5-hydroxytryptamine) in the diencephalic regions of the brain, due to which there is a decrease in food requirements and a decrease in body weight.A number of researchers have shown that the hypoglycemic effect of the drug occurs due to peripheral action. Fenfluramine affects the extraneuronal oxidation of monoamins and reduces the level of tryptophan in the blood. T. Pssquire in experiments on rats confirmed that this effect of the drug is achieved by improving the sensitivity of peripheral tissues to insulin, especially muscles.Some researchers observed a decrease in plasma fatty acids and cholesterol levels during treatment with ferfluramine.However, the issue of the effect of the drug on the residual secretion of the C-peptide of b-cells of the pancreas during treatment with fenfluramine is not covered in the literature available to us.In our study, 26 patients with obesity (the control group consisted of 18 healthy subjects who had previously impaired glucose tolerance) showed that fenfluramine restores phase I of insulin secretion on the background of an intravenous load with glucagon or glucose, and compensation for diabetes mellitus during treatment fenfluramine is apparently associated not only with a direct stimulating effect on the -cells of the islets of Langerhans but also with its peripheral effect.
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7

Sherman, Jeffrey, David C. Factor, Richard Swinson, and Richard W. Darjes. "The effects of fenfluramine (Hydrochloride) on the behaviors of fifteen autistic children." Journal of Autism and Developmental Disorders 19, no. 4 (December 1989): 533–43. http://dx.doi.org/10.1007/bf02212856.

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8

Rajamani, Sridharan, Christian Studenik, Rosa Lemmens-Gruber, and Peter Heistracher. "Cardiotoxic effects of fenfluramine hydrochloride on isolated cardiac preparations and ventricular myocytes of guinea-pigs." British Journal of Pharmacology 129, no. 5 (March 2000): 843–52. http://dx.doi.org/10.1038/sj.bjp.0703118.

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9

Rimland, Bernard. "Controversies in the Treatment of Autistic Children: Vitamin and Drug Therapy." Journal of Child Neurology 3, no. 1_suppl (January 1988): S68—S72. http://dx.doi.org/10.1177/0883073888003001s13.

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A survey of approximately 4,000 questionnaires completed by parents of autistic children provided ratings on a variety of treatments and interventions. Among the biomedical treatments, the use of high-dosage vitamin B6 and magnesium (n = 318) received the highest ratings, with 8.5 parents reporting behavioral improvement to every one reporting behavioral worsening. Deanol (n = 121) was next most highly rated, with 1.8 parents reporting improvement to each one reporting worsening. Fenfluramine (n = 104) was third, with a ratio of 1.5:1. Thioridazine hydrochloride (Mellaril), by far the most often used drug on the list (n = 724), was fourth with a helped-worsened ratio of 1.4:1. The research literature on the use of vitamin B6-magnesium is briefly reviewed, and mention is made of recent findings regarding high-dosage folic acid in autism and biotin in Rett syndrome. (J Child Neurol 1988;3(Suppl):S68-S72).
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10

Lagae, Lieven, Joseph Sullivan, Kelly Knupp, Linda Laux, Tilman Polster, Marina Nikanorova, Orrin Devinsky, et al. "Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: a randomised, double-blind, placebo-controlled trial." Lancet 394, no. 10216 (December 2019): 2243–54. http://dx.doi.org/10.1016/s0140-6736(19)32500-0.

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11

Specchio, Nicola, Nicola Pietrafusa, Viola Doccini, Marina Trivisano, Francesca Darra, Francesca Ragona, Alberto Cossu, et al. "Efficacy and safety of Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: A real‐world study." Epilepsia 61, no. 11 (September 18, 2020): 2405–14. http://dx.doi.org/10.1111/epi.16690.

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12

"Orphan designation: Fenfluramine hydrochloride, Treatment of Dravet syndrome." Case Medical Research, June 3, 2019. http://dx.doi.org/10.31525/cmr-14481fb.

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13

"Orphan designation: Fenfluramine hydrochloride, Treatment of Lennox-Gastaut syndrome." Case Medical Research, June 3, 2019. http://dx.doi.org/10.31525/cmr-1448200.

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14

Schoonjans, An-Sofie, and Berten Ceulemans. "A critical evaluation of fenfluramine hydrochloride for the treatment of Dravet syndrome." Expert Review of Neurotherapeutics, February 26, 2021, 1–14. http://dx.doi.org/10.1080/14737175.2021.1877540.

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15

"A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome." Case Medical Research, May 3, 2019. http://dx.doi.org/10.31525/ct1-nct03936777.

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16

"New product intros [bempedoic acid/ezetimibe (new combination), bulevirtide, copper Cu 64 dotatate, daprodustat, decitabine/cedazuridine (new combination), fenfluramine hydrochloride, indacaterol acetate/glycopyrronium bromide/mometasone furoate (new combination), mitomycin C (new formulation), octreotide acetate (new indication), pemigatinib, pertuzumab/trastuzumab/hyaluronidase-zzxf (new combination), risdiplam, satralizumab, selpercatinib, vadadustat]." Drugs of Today 56, no. 10 (2020): 691. http://dx.doi.org/10.1358/dot.2020.56.10.3227672.

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17

PETIT, M. N., G. COQUEREL, and R. BOUAZIZ. "ChemInform Abstract: The Hydrochlorides of (S) and (RS) Fenfluramine. Stabilities of the Enantiomers and the Racemate in the Melt and in Aqueous Medium." Chemischer Informationsdienst 17, no. 15 (April 15, 1986). http://dx.doi.org/10.1002/chin.198615055.

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