Evidence map›Paper›PMID 31037429›Full record

ArticlePharmaceutical research2019

Pharmacokinetic and Pharmacodynamic Properties of a Micro-Dose Nasal Spray Formulation of Desmopressin (AV002) in Healthy Water-Loaded Subjects.

Karl-Erik Andersson, James Longstreth, Benjamin M Brucker, Lysanne Campeau, Linda Cheng, Leo Francis, Seymour Fein

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Pharmaceutical research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.2field-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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
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

7 authors at 3 institutions in 2 countries.

Karl-Erik AnderssonInstitute for Regenerative Medicine, Wake Forest University School of Medicine, Richard H. Dean Biomedical Building, 391 Technology Way, Winston-Salem, North Carolina, USA. karl-erik.andersson@med.lu.se.
James LongstrethLongstreth & Associates Inc, Mundelein, Illinois, USA.
Benjamin M BruckerDepartment of Urology, Langone Health, New York University, New York, New York, USA.
Lysanne CampeauDivision of Urology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.
Linda ChengSerenity Pharmaceuticals LLC, Milford, Pennsylvania, USA.
Leo FrancisAvadel Specialty Pharmaceuticals plc, Chesterfield, Missouri, USA.
Seymour FeinSerenity Pharmaceuticals LLC, Milford, Pennsylvania, USA.
McGill University · CANYU Langone Health · USWake Forest University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAntidiuretic therapy with desmopressin for nocturia has been hampered by formulations with high doses, low bioavailability and variable pharmacokinetics. AV002 (SER120), a novel, emulsified, microdose desmopressin nasal spray, with a permeation enhancer (cylcopentadecanolide), was developed to have pharmacokinetic characteristics suitable for nocturia treatment.

methodsTwelve healthy subjects participated in an open-label, dose-escalating study. Water-loaded subjects were sequentially dosed every 48 h with AV002 0.5, 1.0, 2.0 μg and 0.12 μg desmopressin subcutaneous (SC) bolus injection.

resultsAV002 intranasal administration produced a time-to-maximum concentration (T

conclusionsAV002 demonstrated rapid absorption, high bioavailability, limited duration of action, and low coefficient of variation, suggesting it may be a suitable formulation for nocturia treatment. Trial registration not required (single-center, phase 1).

Indexed as

Administration, IntranasalAdolescentAdultAntidiuretic AgentsBiological AvailabilityDeamino Arginine VasopressinHealthy VolunteersHumansMaleNasal SpraysYoung AdultAntidiuretic AgentsDeamino Arginine VasopressinNasal Spraysantidiuresisbioavailabilityhyponatremiasafetyurine osmolality

Identifiers

PMID31037429
PMCPMC6488552
OpenAlexW2943104101

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.