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Fixed-dose dextromethorphan/quinidine capsules (Nuedexta®) utilize quinidine to inhibit the metabolism of dextromethorphan, enabling high plasma dextromethorphan concentrations to be reached without using a larger dose of the drug. The drug combination is the first treatment to be approved for pseudobulbar affect (PBA), a condition of contextually inappropriate/exaggerated emotional expression that...
Suvorexant (Belsomra®), a first-in-class, orally active dual orexin-1 receptor and orexin-2 receptor antagonist, has been developed by Merck for the treatment of insomnia. Variations in the levels of the neuropeptides orexin A and orexin B have been linked to circadian rhythms and wakefulness. Orexin-producing neurons in the lateral hypothalamus regulate wakefulness by signalling through orexin receptors...
A fixed-dose combination of sumatriptan/naproxen sodium (Treximet®) has been approved in the US for the acute treatment of migraine in adults. In two randomized trials, sumatriptan/naproxen sodium demonstrated significantly better efficacy than sumatriptan alone, naproxen sodium alone, or placebo as late-intervention therapy for a single migraine episode in adults, as assessed by co-primary efficacy...
Flublok® is a trivalent influenza vaccine manufactured using the baculovirus-insect cell system, which has a number of differences compared with the traditional embryonated chicken egg system. Flublok® is the first vaccine containing recombinant protein to be approved for the prevention of seasonal influenza, and is indicated in the USA in adults aged 18–49 years. In a large, placebo-controlled, phase...
Ospemifene (Osphena™) is an oral selective estrogen receptor modulator (SERM), with tissue-specific estrogenic agonist/antagonist effects. QuatRx Pharmaceuticals conducted the global development of the agent before licensing it to Shionogi for regulatory filing and commercialization worldwide. Ospemifene is the first non-estrogen treatment approved for moderate to severe dyspareunia in women with...
Prednisone is a well-established treatment option in rheumatoid arthritis. Low-dose glucocorticoid therapy alleviates disease signs and symptoms, is better tolerated than high-dose therapy, and its addition to disease-modifying anti-rheumatic drugs (DMARDs) inhibits radiographic disease progression. A low-dose, modified-release (MR) formulation of prednisone, administered in the evening, was developed...
Olodaterol (Striverdi® Respimat®) is a novel, long-acting, β2-adrenergic receptor agonist developed by Boehringer Ingelheim for the treatment of chronic obstructive pulmonary disease (COPD). The drug is delivered via the Respimat® Soft Mist™ inhaler. Olodaterol received its first global approval for the once-daily maintenance treatment of COPD in Canada and Russia, and submissions for regulatory approval...
Ruxolitinib is a selective inhibitor of Janus kinases (JAK) 1 and 2, which are involved in the signalling pathway of various cytokines and growth factors essential to haematopoiesis. JAK 1 and 2 are implicated in the development of myelofibrosis, as well as other haematological malignancies. Ruxolitinib is the first agent approved for the treatment of myelofibrosis.In a randomized, double-blind, placebo-controlled,...
Saxagliptin (Onglyza™) is a dipeptidyl peptidase 4 inhibitor widely approved for the treatment of type 2 diabetes mellitus. In the EU, saxagliptin is indicated as combination therapy with metformin, a sulfonylurea, a thiazolidinedione, or insulin (with or without metformin) for the treatment of adult patients with type 2 diabetes, including those with mild to severe renal impairment. This article...
Axitinib is a new inhibitor of vascular endothelial growth factor (VEGF) receptors 1–3, with greater inhibition potency than existing VEGF receptor inhibitors sunitinib, sorafenib and pazopanib. In a pivotal phase III trial in patients with advanced renal cell carcinoma that had progressed despite first-line therapy, axitinib 5 mg twice daily significantly prolonged median progression-free survival...
Nomegestrol acetate/estradiol is a combined oral contraceptive with approval in many countries. This fixed-dose combination tablet contains nomegestrol acetate, a highly selective progestogen, and estradiol, a natural estrogen. It is the first monophasic combined oral contraceptive to contain estradiol, and is taken in 28-day cycles, consisting of 24 active therapy days with 4 placebo days (i.e. 24/4-day...
Oral abiraterone acetate, in combination with prednisone/prednisolone, is used to treat patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel-containing chemotherapy. Abiraterone acetate was developed to specifically inhibit cytochrome P450 (CYP)17A1, which is an essential enzyme in the biosynthesis of testosterone. In a pivotal phase III trial...
The Multi MatriX system (MMX®) formulation of mesalazine (Lialda®; Mesavancol®; Mezavant®) [henceforth referred to as MMX mesalazine] is an oral, high-dose, once-daily, gastro-resistant, prolonged-release formulation indicated for use in patients with mild to moderate ulcerative colitis. Mesalazine has numerous anti-inflammatory effects on the mucosa of the colon, parts of which are frequently inflamed...
Oral colchicine (Colcrys®) is approved in the US for the treatment of acute gout flares in adult patients and the prophylaxis of gout flares in patients aged >16 years.Colchicine is a tricyclic alkaloid that interrupts multiple inflammatory response pathways. Its principal mechanism of action in gout is thought to be inhibition of cytoskeletal microtubule polymerization, an important process in...
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