Sublingual apomorphine (APL-130277) for the acute conversion of OFF to ON in Parkinson's disease.
Identifieur interne : 000168 ( PubMed/Curation ); précédent : 000167; suivant : 000169Sublingual apomorphine (APL-130277) for the acute conversion of OFF to ON in Parkinson's disease.
Auteurs : Robert A. Hauser [États-Unis] ; C Warren Olanow [États-Unis] ; Bruce Dzyngel [Canada] ; Thierry Bilbault [Canada] ; Holly Shill [États-Unis] ; Stuart Isaacson [États-Unis] ; Jordan Dubow [Canada] ; Albert Agro [Canada]Source :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2016.
Abstract
OFF episodes negatively impact quality of life in patients with Parkinson's disease (PD). There remains a need for an acute, effective, noninvasive treatment.
DOI: 10.1002/mds.26697
PubMed: 27430123
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Hauser</name><affiliation wicri:level="1"><nlm:affiliation>University of South Florida Health Byrd Parkinson's Disease and Movement Disorders Center of Excellence, Tampa, Florida, USA. rhauser@health.usf.edu.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of South Florida Health Byrd Parkinson's Disease and Movement Disorders Center of Excellence, Tampa, Florida</wicri:regionArea></affiliation></author><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C Warren" last="Olanow">C Warren Olanow</name><affiliation wicri:level="1"><nlm:affiliation>Departments of Neurology and Neuroscience, Mount Sinai School of Medicine, New York, New York, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Departments of Neurology and Neuroscience, Mount Sinai School of Medicine, New York, New York</wicri:regionArea></affiliation></author><author><name sortKey="Dzyngel, Bruce" sort="Dzyngel, Bruce" uniqKey="Dzyngel B" first="Bruce" last="Dzyngel">Bruce Dzyngel</name><affiliation wicri:level="1"><nlm:affiliation>Cynapsus Therapeutics, Inc, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Cynapsus Therapeutics, Inc, Toronto, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Bilbault, Thierry" sort="Bilbault, Thierry" uniqKey="Bilbault T" first="Thierry" last="Bilbault">Thierry Bilbault</name><affiliation wicri:level="1"><nlm:affiliation>Cynapsus Therapeutics, Inc, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Cynapsus Therapeutics, Inc, Toronto, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Shill, Holly" sort="Shill, Holly" uniqKey="Shill H" first="Holly" last="Shill">Holly Shill</name><affiliation wicri:level="1"><nlm:affiliation>Barrow Neurological Institute, Phoenix, Arizona, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Barrow Neurological Institute, Phoenix, Arizona</wicri:regionArea></affiliation></author><author><name sortKey="Isaacson, Stuart" sort="Isaacson, Stuart" uniqKey="Isaacson S" first="Stuart" last="Isaacson">Stuart Isaacson</name><affiliation wicri:level="1"><nlm:affiliation>Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida</wicri:regionArea></affiliation></author><author><name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name><affiliation wicri:level="1"><nlm:affiliation>Cynapsus Therapeutics, Inc, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Cynapsus Therapeutics, Inc, Toronto, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Agro, Albert" sort="Agro, Albert" uniqKey="Agro A" first="Albert" last="Agro">Albert Agro</name><affiliation wicri:level="1"><nlm:affiliation>Cynapsus Therapeutics, Inc, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Cynapsus Therapeutics, Inc, Toronto, Ontario</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27430123</idno><idno type="pmid">27430123</idno><idno type="doi">10.1002/mds.26697</idno><idno type="wicri:Area/PubMed/Corpus">000168</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000168</idno><idno type="wicri:Area/PubMed/Curation">000168</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000168</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Sublingual apomorphine (APL-130277) for the acute conversion of OFF to ON in Parkinson's disease.</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><affiliation wicri:level="1"><nlm:affiliation>University of South Florida Health Byrd Parkinson's Disease and Movement Disorders Center of Excellence, Tampa, Florida, USA. rhauser@health.usf.edu.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of South Florida Health Byrd Parkinson's Disease and Movement Disorders Center of Excellence, Tampa, Florida</wicri:regionArea></affiliation></author><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C Warren" last="Olanow">C Warren Olanow</name><affiliation wicri:level="1"><nlm:affiliation>Departments of Neurology and Neuroscience, Mount Sinai School of Medicine, New York, New York, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Departments of Neurology and Neuroscience, Mount Sinai School of Medicine, New York, New York</wicri:regionArea></affiliation></author><author><name sortKey="Dzyngel, Bruce" sort="Dzyngel, Bruce" uniqKey="Dzyngel B" first="Bruce" last="Dzyngel">Bruce Dzyngel</name><affiliation wicri:level="1"><nlm:affiliation>Cynapsus Therapeutics, Inc, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Cynapsus Therapeutics, Inc, Toronto, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Bilbault, Thierry" sort="Bilbault, Thierry" uniqKey="Bilbault T" first="Thierry" last="Bilbault">Thierry Bilbault</name><affiliation wicri:level="1"><nlm:affiliation>Cynapsus Therapeutics, Inc, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Cynapsus Therapeutics, Inc, Toronto, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Shill, Holly" sort="Shill, Holly" uniqKey="Shill H" first="Holly" last="Shill">Holly Shill</name><affiliation wicri:level="1"><nlm:affiliation>Barrow Neurological Institute, Phoenix, Arizona, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Barrow Neurological Institute, Phoenix, Arizona</wicri:regionArea></affiliation></author><author><name sortKey="Isaacson, Stuart" sort="Isaacson, Stuart" uniqKey="Isaacson S" first="Stuart" last="Isaacson">Stuart Isaacson</name><affiliation wicri:level="1"><nlm:affiliation>Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida</wicri:regionArea></affiliation></author><author><name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name><affiliation wicri:level="1"><nlm:affiliation>Cynapsus Therapeutics, Inc, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Cynapsus Therapeutics, Inc, Toronto, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Agro, Albert" sort="Agro, Albert" uniqKey="Agro A" first="Albert" last="Agro">Albert Agro</name><affiliation wicri:level="1"><nlm:affiliation>Cynapsus Therapeutics, Inc, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Cynapsus Therapeutics, Inc, Toronto, Ontario</wicri:regionArea></affiliation></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">OFF episodes negatively impact quality of life in patients with Parkinson's disease (PD). There remains a need for an acute, effective, noninvasive treatment.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">27430123</PMID><DateCreated><Year>2016</Year><Month>09</Month><Day>07</Day></DateCreated><DateRevised><Year>2016</Year><Month>09</Month><Day>07</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>31</Volume><Issue>9</Issue><PubDate><Year>2016</Year><Month>Sep</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Sublingual apomorphine (APL-130277) for the acute conversion of OFF to ON in Parkinson's disease.</ArticleTitle><Pagination><MedlinePgn>1366-72</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.26697</ELocationID><Abstract><AbstractText Label="INTRODUCTION" NlmCategory="BACKGROUND">OFF episodes negatively impact quality of life in patients with Parkinson's disease (PD). There remains a need for an acute, effective, noninvasive treatment.</AbstractText><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">APL-130277 is a sublingually administered apomorphine oral strip.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">The authors conducted a phase 2, open-label, proof-of-concept study. Patients presented to clinic in the morning in the practically defined OFF state and were dosed with APL-130277 10 mg. Assessments of OFF or ON state and MDS-UPDRS part III were conducted predose and at 15, 30, 45, 60, and 90 minutes. If a full ON was not achieved within 3 hours, the dose was increased in 5 mg increments until a full ON was achieved or to a maximum dose of 30 mg. Patients could be dosed up to two times a day over 3 days. Patients were pretreated with trimethobenzamide for 3 days, which was continued during the study.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Of 19 patients, 15 (78.9%) achieved a full ON response. All 15 achieved a full ON response within 30 minutes and 6 of the 15 patients (40.0%) achieved a full ON response within 15 minutes. The mean (SD) duration of ON was 50 (19.4) minutes. Of the 15 patients, 9 (60.0%) remained fully ON for ≥90 minutes. There were no discontinuations as a result of an adverse event. The most common adverse events were dizziness (36.8%), somnolence (31.6%), and nausea (21.1%).</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">This was the first study of a new sublingual apomorphine formulation in PD patients. In this open-label study, APL-130277 appeared to provide a convenient, rapid, and reliable method for treating OFF episodes. © 2016 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.</AbstractText><CopyrightInformation>© 2016 International Parkinson and Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Hauser</LastName><ForeName>Robert A</ForeName><Initials>RA</Initials><AffiliationInfo><Affiliation>University of South Florida Health Byrd Parkinson's Disease and Movement Disorders Center of Excellence, Tampa, Florida, USA. rhauser@health.usf.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Olanow</LastName><ForeName>C Warren</ForeName><Initials>CW</Initials><AffiliationInfo><Affiliation>Departments of Neurology and Neuroscience, Mount Sinai School of Medicine, New York, New York, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dzyngel</LastName><ForeName>Bruce</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Cynapsus Therapeutics, Inc, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bilbault</LastName><ForeName>Thierry</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Cynapsus Therapeutics, Inc, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shill</LastName><ForeName>Holly</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Barrow Neurological Institute, Phoenix, Arizona, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Isaacson</LastName><ForeName>Stuart</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dubow</LastName><ForeName>Jordan</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Cynapsus Therapeutics, Inc, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Agro</LastName><ForeName>Albert</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Cynapsus Therapeutics, Inc, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>07</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">APL-130277</Keyword><Keyword MajorTopicYN="N">OFF periods</Keyword><Keyword MajorTopicYN="N">Parkinson's disease</Keyword><Keyword MajorTopicYN="N">apomorphine</Keyword><Keyword MajorTopicYN="N">fluctuations</Keyword><Keyword MajorTopicYN="N">sublingual</Keyword><Keyword MajorTopicYN="N">treatment</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>12</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>04</Month><Day>28</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>05</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>7</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>7</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>7</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27430123</ArticleId><ArticleId IdType="doi">10.1002/mds.26697</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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