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Indacaterol: Difference between revisions

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| excretion =
| excretion =
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_US = <!-- A / B / C / D / X -->
| pregnancy_US = C
| pregnancy_category=
| pregnancy_category=
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->
| legal_UK = POM
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_US = Rx-only
| legal_status = Rx-only
| legal_status =
| routes_of_administration = Inhalation
| routes_of_administration = Inhalation
| licence_EU = Onbrez
| licence_US = Indacaterol
}}
}}
'''Indacaterol''' ([[International Nonproprietary Name|INN]]) is an ultra-[[long-acting beta-adrenoceptor agonist]]<ref name="pmid16022567">{{cite journal |author=Cazzola M, Matera MG, Lötvall J |title=Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease |journal=Expert Opin Investig Drugs |volume=14 |issue=7 |pages=775–83 |year=2005 |month=July |pmid=16022567 |doi=10.1517/13543784.14.7.775 |url=}}</ref> developed by by [[Novartis]].It was approved by the [[European Medicines Agency]] (EMA) under the trade name Onbrez on November 30, 2009,<ref>[http://www.ema.europa.eu/humandocs/Humans/EPAR/onbrez_breezhaler/onbrez_breezhaler.htm European Public Assessment Report for Onbrez Breezhaler]</ref> and by the [[United States Food and Drug Administration]] (FDA), under the trade name Arcapta Neohaler, on July 1, 2011.<ref>{{cite press release |url=http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261649.htm |title=FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease |publisher=U.S. Food and Drug Administration |date=2011-07-01 |accessdate=2011-07-02}}[http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261649.htm]</ref> It needs to be taken only once a day,<ref name="pmid17251236">{{cite journal |author=Beeh KM, Derom E, Kanniess F, Cameron R, Higgins M, van As A |title=Indacaterol, a novel inhaled beta2-agonist, provides sustained 24-h bronchodilation in asthma |journal=Eur. Respir. J. |volume=29 |issue=5 |pages=871–8 |year=2007 |month=May |pmid=17251236 |doi=10.1183/09031936.00060006 |url=}}</ref> unlike the currently available [[formoterol]] and [[salmeterol]]. It is licensed only for the treatment of [[chronic obstructive pulmonary disease]] (COPD) (long-term data in patients with [[asthma]] are thus far lacking). It is delivered as an aerosol formulation through a [[dry powder inhaler]].
'''Indacaterol''' ([[International Nonproprietary Name|INN]]) is an ultra-[[long-acting beta-adrenoceptor agonist]]<ref name="pmid16022567">{{cite journal |author=Cazzola M, Matera MG, Lötvall J |title=Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease |journal=Expert Opin Investig Drugs |volume=14 |issue=7 |pages=775–83 |year=2005 |month=July |pmid=16022567 |doi=10.1517/13543784.14.7.775 |url=}}</ref> developed by by [[Novartis]].It was approved by the [[European Medicines Agency]] (EMA) under the trade name Onbrez on November 30, 2009,<ref>[http://www.ema.europa.eu/humandocs/Humans/EPAR/onbrez_breezhaler/onbrez_breezhaler.htm European Public Assessment Report for Onbrez Breezhaler]</ref> and by the [[United States Food and Drug Administration]] (FDA), under the trade name Arcapta Neohaler, on July 1, 2011.<ref>{{cite press release |url=http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261649.htm |title=FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease |publisher=U.S. Food and Drug Administration |date=2011-07-01 |accessdate=2011-07-02}}[http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261649.htm]</ref> It needs to be taken only once a day,<ref name="pmid17251236">{{cite journal |author=Beeh KM, Derom E, Kanniess F, Cameron R, Higgins M, van As A |title=Indacaterol, a novel inhaled beta2-agonist, provides sustained 24-h bronchodilation in asthma |journal=Eur. Respir. J. |volume=29 |issue=5 |pages=871–8 |year=2007 |month=May |pmid=17251236 |doi=10.1183/09031936.00060006 |url=}}</ref> unlike the currently available [[formoterol]] and [[salmeterol]]. It is licensed only for the treatment of [[chronic obstructive pulmonary disease]] (COPD) (long-term data in patients with [[asthma]] are thus far lacking). It is delivered as an aerosol formulation through a [[dry powder inhaler]].

Revision as of 16:26, 11 July 2011

Indacaterol
Clinical data
License data
Routes of
administration		Inhalation
ATC code
Legal status
Legal status
Identifiers
  • (R)-5-[2-[(5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxyquinolin-2(1H)-one
CAS Number
PubChem CID
ChemSpider
UNII
KEGG
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.218.577 Edit this at Wikidata
Chemical and physical data
FormulaC24H28N2O3
Molar mass392.490 g/mol g·mol−1
3D model (JSmol)
  • O=C4/C=C\c1c(c(O)ccc1[C@@H](O)CNC3Cc2cc(c(cc2C3)CC)CC)N4
  • InChI=1S/C24H28N2O3/c1-3-14-9-16-11-18(12-17(16)10-15(14)4-2)25-13-22(28)19-5-7-21(27)24-20(19)6-8-23(29)26-24/h5-10,18,22,25,27-28H,3-4,11-13H2,1-2H3,(H,26,29)/t22-/m0/s1 checkY
  • Key:QZZUEBNBZAPZLX-QFIPXVFZSA-N checkY
 ☒NcheckY (what is this?)  (verify)

Indacaterol (INN) is an ultra-long-acting beta-adrenoceptor agonist[1] developed by by Novartis.It was approved by the European Medicines Agency (EMA) under the trade name Onbrez on November 30, 2009,[2] and by the United States Food and Drug Administration (FDA), under the trade name Arcapta Neohaler, on July 1, 2011.[3] It needs to be taken only once a day,[4] unlike the currently available formoterol and salmeterol. It is licensed only for the treatment of chronic obstructive pulmonary disease (COPD) (long-term data in patients with asthma are thus far lacking). It is delivered as an aerosol formulation through a dry powder inhaler.

Clinical trials

A Phase III trial published in March 2010 examined the efficacy and safety of indacaterol in COPD patients.[5] This study, conducted in the U.S., New Zealand, and Belgium, compared indacaterol dry-powder inhaler to placebo in 416 COPD patients, mostly moderate to severe (mean FEV1 of 1.5 L). Indacaterol produced statistically improved FEV1 (both trough and AUC) and decreased use of rescue medication compared to placebo, but with safety and tolerability similar to those of placebo.

A year-long, placebo-controlled trial published in July 2010 suggests indacaterol may be significantly more effective than twice-daily formoterol in improving FEV1. There were some reductions in the need for rescue medication, but these were not significantly different; nor was there any difference in the rate of exacerbation between the 2 active treatments.[6]

References

  1. ^ Cazzola M, Matera MG, Lötvall J (2005). "Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease". Expert Opin Investig Drugs. 14 (7): 775–83. doi:10.1517/13543784.14.7.775. PMID 16022567. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  2. ^ European Public Assessment Report for Onbrez Breezhaler
  3. ^ "FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease" (Press release). U.S. Food and Drug Administration. 2011-07-01. Retrieved 2011-07-02.[1]
  4. ^ Beeh KM, Derom E, Kanniess F, Cameron R, Higgins M, van As A (2007). "Indacaterol, a novel inhaled beta2-agonist, provides sustained 24-h bronchodilation in asthma". Eur. Respir. J. 29 (5): 871–8. doi:10.1183/09031936.00060006. PMID 17251236. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  5. ^ Feldman, G; Siler, T; Prasad, N; Jack, D; Piggott, S; Owen, R; Higgins, M; Kramer, B; Study Group, I (2010). "Efficacy and safety of indacaterol 150 mcg once-daily in COPD: a double-blind, randomised, 12-week study". BMC pulmonary medicine. 10: 11. doi:10.1186/1471-2466-10-11. PMC 2848004. PMID 20211002.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  6. ^ Dahl R, Chung KF, Buhl R; et al. (2010). "Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD". Thorax. 65 (6): 473–9. doi:10.1136/thx.2009.125435. PMID 20522841. {{cite journal}}: Explicit use of et al. in: |author= (help); Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)


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