Evidence map›Paper›PMID 37365668›Full record

ArticleJournal of eating disorders2023

SipNose-topiramate: a potential novel approach to binge eating management.

Ayala Kobo-Greenhut, Adit Zohar-Beja, Liron Hadar, Lior Itzhaki, Avraham Karasik, Yoseph Caraco, Hilel Frankenthal, Daniel Shahaf, Dana Ekstein, Iris Shichor and 1 more

Open access · goldAbstract read
In one paragraph

Article in Journal of eating disorders, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.3field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

Ayala Kobo-Greenhut *Risk Management, Validation, Regulation, Haifa, Israel.
Adit Zohar-Beja *Eating Disorder Department, Sheba Medical Center, Tel HaShomer, Israel.
Liron HadarSipNose Ltd., Yokneam, Israel.
Lior ItzhakiSipNose Ltd., Yokneam, Israel.
Avraham KarasikSipNose Ltd., Yokneam, Israel.
Yoseph CaracoClinical Pharmacology Unit, Division of Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
Hilel FrankenthalZiv Medical Center, Safed, Israel.
Daniel ShahafSipNose Ltd., Yokneam, Israel.
Dana EksteinDepartment of Neurology and Agnes Ginges Center for Neurogenetics, Hadassah Medical Center, Jerusalem, Israel.
Iris Shichor *SipNose Ltd., Yokneam, Israel. iris@sipnose.com.
Eitan Gur *Eating Disorder Department, Sheba Medical Center, Tel HaShomer, Israel.
SipNose (Israel) · ILSheba Medical Center · ILHadassah Medical Center · ILHebrew University of Jerusalem · ILRebecca Sieff Hospital · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBinge-eating disorder) BED) is the most common eating disorder in the United-States. Daily, orally administered topiramate has shown BED treatment efficacy, with two major limitations: frequent and severe side effects and slow time-to-effect. SipNose is a novel non-invasive intranasal direct nose-to-brain drug delivery platform that delivers drugs to the central nervous system consistently and rapidly. Herein, we study a SipNose-topiramate combination product, as an acute "as needed" (PRN) solution for BED management.

methodsFirst, SipNose-topiramate's pharmacokinetics (PK) and safety was evaluated. The second part aimed to demonstrate its PRN-treatment feasibility in terms of usability and potential efficacy in reducing the number of binge-eating events. Twelve BED patients were studied over three time periods; 2-weeks of baseline monitoring [BL], 8-weeks of treatment [TX], and 2-weeks of follow up [FU].

resultsThe PK profile showed peak plasma levels at 90 min post-administration, a t

conclusionsThis study introduces a SipNose-topiramate drug-device combination as a potentially safe, effective, and controlled method for BED management. Its findings introduce a potential approach to BED management both as an intranasal and as a PRN therapy for reducing binge-eating events, with a large-scale reduction in patient drug exposure and side effects and with improved patient quality of life. Further studies are needed with larger patient populations to establish SipNose-topiramate as a mainstream treatment for BED.

trial registrationRegistration number and date of registration of the clinical studies reported in this article are as follows: 0157-18-HMO, August 15th 2018 and 6814-20-SMC, December 2nd 2020.

Indexed as

Binge eating disorderDirect nose-to-brainSipNose-topiramate

Identifiers

PMID37365668
PMCPMC10294342
OpenAlexW4382139061

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.