Drugs in R&D
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Randomized Controlled Trial
Pharmacokinetics, safety and tolerability of Bencycloquidium bromide, a novel selective muscarinic M1/M3 receptor antagonist, after single and multiple intranasal doses in healthy chinese subjects: an open-label, single-center, first-in-human study.
Bencycloquidium bromide (BCQB) is a novel, potent and selective muscarinic M1/M3 receptor antagonist under development for the treatment of rhinorrhea in rhinitis. The pharmacokinetics and safety of BCQB in animals have been established in preclinical studies. However, no clinical pharmacokinetic data are available for BCQB in humans. ⋯ BCQB was safe and well tolerated in healthy Chinese subjects when administered intranasally with single and multiple doses across the doses studied. The mean C(max) and AUC increased proportionally to the studied doses, and the steady state was achieved within 3 days after three times daily dosing. A slight accumulation of BCQB following multiple dosing was observed. The pharmacokinetics, safety and tolerability profiles of BCQB pose it as a good candidate for further development in the treatment of rhinorrhea in rhinitis.
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Randomized Controlled Trial
Ultrasound-guided injection of a corticosteroid and hyaluronic acid: a potential new approach to the treatment of trigger finger.
Stenosing tenosynovitis (trigger finger) is one of the most common causes of pain and disability in the hand, which may often require treatment with anti-inflammatory drugs, corticosteroid injection, or open surgery. However, there is still large room for improvement in the treatment of this condition by corticosteroid injection. The mechanical, visco-elastic, and antinociceptive properties of hyaluronic acid may potentially support the use of this molecule in association with corticosteroids for the treatment of trigger finger. This study examines the feasibility and safety of ultrasound-guided injection of a corticosteroid and hyaluronic acid compared, for the first time, with open surgery for the treatment of trigger finger. ⋯ Although the limited sample size did not allow any statistical comparison between treatment groups, and therefore all the findings should be regarded as preliminary, the results of this explorative study suggest that ultrasound-guided injection of a corticosteroid and hyaluronic acid could be a safe and feasible approach for the treatment of trigger finger. It is also associated with a shorter recovery time than open surgery, which leads to a reduced abstention from sports and, in particular, work activities, and therefore may have some pharmacoeconomic implications, which may be further explored. In light of the promising results obtained in this investigation, further studies comparing ultrasound-guided injection of corticosteroid plus hyaluronic acid with corticosteroid alone are recommended in order to clarify the actual benefits attributable to hyaluronic acid.
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Clinical Trial
Different doses of palonosetron for the prevention of postoperative nausea and vomiting in children undergoing strabismus surgery.
Postoperative vomiting is a common complication after strabismus surgery in children. The serotonin 5-HT(3) receptor antagonists have proven to be a particularly valuable addition to the armamentarium against postoperative nausea and vomiting (PONV). Palonosetron is a second-generation 5-HT(3) receptor antagonist that has recently been approved for prophylaxis against PONV. ⋯ Palonosetron doses of 0.5, 1.0, and 1.5 μg/kg are recommended for further evaluation, as they appear to be the effective doses for the prevention of PONV following strabismus surgery in children.
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Belimumab is a fully human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS. Belimumab is in phase III trials for the treatment of systemic lupus erythematosus (SLE) and has completed a phase II trial in rheumatoid arthritis (RA); the product may also have potential in the treatment of other autoimmune disorders. In May 2001, Cambridge Antibody Technology (now MedImmune) completed its discovery programme and Human Genome Sciences identified belimumab as a candidate for clinical development. ⋯ Results from a phase II trial in 449 patients with SLE demonstrated that belimumab improved or stabilized SLE over 2.5 years. The phase II trial was a double-blind, placebo-controlled, multicentre study that evaluated the safety, optimal dosing, and preliminary efficacy of belimumab in patients with active SLE over 52 weeks initially, followed by a continuation phase for a total of 2.5 years. Belimumab has received fast-track designation for the treatment of SLE from the US FDA and has also been selected for inclusion in the agency's continuous Marketing Application Pilot 2 programme.
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Treatment of neuropathic pain remains a challenge and the role of various analgesics in this setting is still debated. The effects of tramadol, an atypically acting analgesic with a combined opioid and monoaminergic mechanism of action, and morphine, a prototypical opioid, were tested in rat models of neuropathic and nociceptive pain. ⋯ The results of this study are consistent with clinical data supporting the efficacy of opioids in neuropathic pain conditions, and furthermore suggest an additional contribution of the monoaminergic mechanism of tramadol in the treatment of neuropathic pain states.