PMID- 25162604
OWN - NLM
STAT- MEDLINE
DCOM- 20150415
LR  - 20140828
IS  - 1551-7489 (Print)
IS  - 1551-7489 (Linking)
VI  - 10
IP  - 4
DP  - 2014 Jul-Aug
TI  - Lack of correlation between the effective dose of fentanyl sublingual spray for 
      breakthrough cancer pain and the around-the-clock opioid dose.
PG  - 247-54
LID - jom.2014.0212 [pii]
LID - 10.5055/jom.2014.0212 [doi]
AB  - OBJECTIVE: To examine the relationship between the dose of fentanyl sublingual 
      spray needed to control breakthrough cancer pain (BTCP) and the dose of 
      around-the-clock (ATC) opioid used to control background pain. DESIGN: Analysis 
      was based on the open-label, dose-titration phase (up to 26 days) of a 
      randomized, double-blind, placebo-controlled trial. PATIENTS: Opioid-tolerant 
      cancer patients (aged >/=18 years) with chronic pain of </=moderate severity in the 
      24 hours before screening while receiving stable doses of scheduled ATC opioid 
      therapy for >/=1 week and 1 to 4 episodes of BTCP per day. INTERVENTIONS: Fentanyl 
      sublingual spray was initiated at 100 microg. Dose titration proceeded until a dose 
      was reached that provided adequate pain relief for two consecutive BTCP episodes 
      without intolerable adverse effects (AEs). RESULTS: Overall, 98/130 (75.4 
      percent) patients completed the dose-titration phase and achieved pain relief, 
      and 73.5 percent of those who completed the titration period attained an 
      effective dose of >/=600 microg (median effective dose, 800 microg). No clinically relevant 
      correlation was found between effective doses of fentanyl sublingual spray for 
      the treatment of BTCP and the ATC opioid doses used to control persistent pain 
      (Spearman rank correlation [rs]=0.351, n=98). Sixty percent of patients reported 
      >/=1 AE during the dose-titration phase. The most common AEs considered related to 
      study treatment were nausea (6.2 percent), somnolence (4.6 percent), dizziness 
      (3.8 percent), and vomiting (3.8 percent). CONCLUSIONS: These findings highlight 
      the importance of titrating the dose of fentanyl sublingual spray to optimize 
      dosing for individual patients.
FAU - Nalamachu, Srinivas R
AU  - Nalamachu SR
AD  - International Clinical Research Institute, Overland Park, Kansas.
FAU - Parikh, Neha
AU  - Parikh N
AD  - INSYS Therapeutics, Inc., Chandler, Arizona.
FAU - Dillaha, Larry
AU  - Dillaha L
AD  - NSYS Therapeutics, Inc., Chandler, Arizona.
FAU - Rauck, Richard
AU  - Rauck R
AD  - The Center for Clinical Research, Winston-Salem, North Carolina.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Opioid Manag
JT  - Journal of opioid management
JID - 101234523
RN  - 0 (Aerosols)
RN  - 0 (Analgesics, Opioid)
RN  - UF599785JZ (Fentanyl)
SB  - IM
MH  - Administration, Sublingual
MH  - Adult
MH  - *Aerosols
MH  - Aged
MH  - Analgesics, Opioid/*administration & dosage/adverse effects
MH  - Breakthrough Pain/diagnosis/*drug therapy/etiology
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Tolerance
MH  - Female
MH  - Fentanyl/*administration & dosage/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/*complications
MH  - Pain Measurement
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2014/08/28 06:00
MHDA- 2015/04/16 06:00
CRDT- 2014/08/28 06:00
PHST- 2014/03/07 00:00 [received]
PHST- 2014/06/23 00:00 [accepted]
PHST- 2014/08/28 06:00 [entrez]
PHST- 2014/08/28 06:00 [pubmed]
PHST- 2015/04/16 06:00 [medline]
AID - jom.2014.0212 [pii]
AID - 10.5055/jom.2014.0212 [doi]
PST - ppublish
SO  - J Opioid Manag. 2014 Jul-Aug;10(4):247-54. doi: 10.5055/jom.2014.0212.