Safety and tolerability of extended-release acetylsalicylic acid capsules: a summary of double-blind comparative studies.

Aim: To evaluate tolerability of a new extended-release acetylsalicylic acid (ER-ASA).

Materials & Methods: Daily ER-ASA (162.5-1300 mg) for up to 6 weeks was evaluated (four studies; n = 565).

Effective Dose Titration of Fentanyl Sublingual Spray in Patients With Breakthrough Cancer Pain.

Objective: To further describe effective dose titration of fentanyl sublingual spray to treat breakthrough cancer pain (BTCP) during the 26-day open-label titration phase of a phase 3, randomized, double-blind, placebo-controlled study.

Methods: Opioid-tolerant patients with 1 to 4 episodes of BTCP per day were enrolled. For randomization into double-blind treatment, patients must have titrated to a dose (100 to 1,600 mcg) providing effective analgesia for 2 consecutive BTCP episodes.

A randomized trial to assess the pharmacodynamics and pharmacokinetics of a single dose of an extended-release aspirin formulation.

Aims: Low-dose acetylsalicylic acid (ASA; aspirin) for secondary prevention reduces cardiovascular disease mortality risk. ASA acetylates cyclooxygenase in the portal circulation and is rapidly (half-life, 20 min) hydrolyzed. Certain patients with cardiovascular disease may exhibit high on-therapy platelet reactivity as a result of high platelet turnover, a process whereby platelets are produced and are active beyond the duration of antiplatelet coverage provided by once-daily immediate-release (IR) ASA.

Lack of correlation between the effective dose of fentanyl sublingual spray for breakthrough cancer pain and the around-the-clock opioid dose.

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.

Patient Satisfaction with Fentanyl Sublingual Spray in Opioid-Tolerant Patients with Breakthrough Cancer Pain.

Objectives: Breakthrough cancer pain (BTCP) is associated with decreased satisfaction with around-the-clock opioid therapy. This analysis examined patient satisfaction with fentanyl sublingual spray for BTCP during the open-label titration period of a randomized, placebo-controlled study.

Methods: Opioid-tolerant patients with 1 to 4 daily BTCP episodes were included.

Pharmacokinetics and dose proportionality of fentanyl sublingual spray: a single-dose 5-way crossover study.

Background: Fentanyl sublingual spray is a novel formulation of fentanyl for sublingual delivery that was designed to enhance the rate and extent of absorption of fentanyl for management of breakthrough cancer pain (BTCP).

Objectives: The primary objective of this study was to determine the pharmacokinetics and dose proportionality of 5 different doses (100, 200, 400, 600, and 800 μg) of fentanyl sublingual spray in healthy subjects under fasted conditions (part A); the secondary objective was to assess the effects of temperature and pH in the oral cavity on relative bioavailability of fentanyl (part B).

Methods: Analyses were performed on venous blood samples drawn 5 min to 36 h after administration of fentanyl sublingual spray (Subsys(®), Insys Therapeutics, Inc.

Single-dose pharmacokinetics of fentanyl sublingual spray and oral transmucosal fentanyl citrate in healthy volunteers: a randomized crossover study.

Background: Fentanyl sublingual spray (FSS) is a novel fentanyl formulation recently developed for the treatment of breakthrough cancer pain, which is characterized by a fast onset and a relatively short duration.

Objective: To compare rate of absorption and systemic bioavailability between FSS and oral transmucosal fentanyl citrate (OTFC) in healthy volunteers.

Methods: This randomized 3-way crossover study involved 29 healthy volunteers (25 men and 4 women; mean age, 35 years) who received single doses of FSS (400 μg), OTFC (400 μg), and intravenous fentanyl citrate (100 μg) separated by washout periods of ≥7 days.

Efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain: a randomized, double-blind, placebo-controlled study.

Background And Objectives: A number of transmucosal fentanyl formulations have been developed for the management of breakthrough cancer pain (BTCP). Sublingual delivery of fentanyl, formulated as fentanyl sublingual spray, offers the potential for more rapid and greater absorption of fentanyl and associated onset of analgesic effect compared with other formulations. The objective of this study was to assess the efficacy and safety of fentanyl sublingual spray for the treatment of BTCP.