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A section 2 medical trial led by Stephanie N. Taylor, MD, Professor of Medication and Microbiology within the Part of Infectious Illnesses at LSU Well being New Orleans College of Medication, has discovered new antibiotic successfully treats uncomplicated urogenital and rectal gonorrhea infections in a single oral dose. Outcomes are printed within the November eight, 2018, subject of the New England Journal of Medication.

“Based on the Facilities for Illness Management and Prevention, the incidence of gonorrhea within the US elevated by 67% from 2013 to 2017,” notes Dr. Taylor. “The micro organism inflicting gonorrhea, Neisseria gonorrhoeae, has developed resistance to each class of antibiotic at present advisable for remedy, and studies of multidrug-resistant N. gonorrhoeae necessitate the pressing improvement of recent antimicrobial brokers.”

The researchers carried out a randomized, open-label section 2 medical trial to find out the security and effectiveness of the investigational drug, zoliflodacin, in treating uncomplicated gonorrhea infections. Zoliflodacin, which has been fast-tracked by the FDA, works in a different way from the antibiotics at present accessible to deal with gonorrhea. It inhibits DNA biosynthesis in a brand new approach, impeding bacterial development. Entasis Therapeutics in Waltham, MA developed zoliflodacin.With a purpose of 144 individuals with gonorrhea, a complete of 179 individuals had been enrolled at sexual well being clinics in New Orleans, Seattle, Indianapolis, Birmingham and Durham, North Carolina from November 2014 by way of December 2015. The boys and non-pregnant girls, 18 – 55 years previous, had been eligible if that they had indicators and signs of urogenital gonorrhea, untreated urogenital gonorrhea or sexual contact within the previous 14 days with an individual who had gonorrhea. Urethral, cervical, pharyngeal and rectal swabs had been taken at enrollment. Thirty-eight individuals had been excluded resulting from unfavourable cultures. Individuals had been randomly assigned to obtain a single, oral dose of both 2 or Three grams of zoliflodacin or a single injected dose of 500 mg of ceftriaxone, one of many two medication at present used to deal with gonorrhea.

The microbiologic intention-to-treat (micro-ITT) group (141 individuals) included all individuals with gonorrhea at urethral or cervical websites. The per-protocol group included the individuals within the micro-ITT group who met all inclusion standards, didn’t have one other an infection apart from chlamydia or bacterial vaginosis, didn’t obtain every other systemic antibiotic earlier than check of treatment and returned for a test-of-cure go to inside a six-day window.

The first measure of efficacy was the proportion of individuals with urogenital infections who had been cured. The secondary measure of effectiveness was the variety of individuals whose pharyngeal and rectal infections had been cured. The first security consequence measure was the proportion of individuals reporting hostile occasions.

Therapy with 2 or Three g of zoliflodacin resulted in a 96% treatment charge in these with urogenital infections within the micro-ITT group, whereas the treatment charge for these handled with ceftriaxone was 100%. Within the per-protocol group, 98% of the individuals who took the 2-gram dose of zoliflodacin and 100% of those that acquired the Three-gram dose, in addition to the entire individuals within the ceftriaxone group, had been cured. All of these with rectal infections who had been handled no matter dose or remedy had been cured. Pharyngeal infections had been cured in four of eight individuals (50%), 9 of 11 individuals (82%), and four of four individuals (100%) within the teams that acquired 2 g of zoliflodacin, Three g of zoliflodacin, and ceftriaxone, respectively.

A complete of 21 hostile occasions had been related to zoliflodacin, largely gastrointestinal. Within the ceftriaxone group, 23 hostile occasions had been reported.

“Ceftriaxone is considered one of two medication used as the present customary of care to deal with uncomplicated gonorrhea,” provides Taylor. “A cephalosporin, it’s the final class of antibiotics we have now to deal with gonorrhea. Whereas it has labored effectively, we’re beginning to see resistance to it, too. Since there isn’t any vaccine to stop gonorrhea, and the opportunity of untreatable gonorrhea is looming bigger, it’s crucial that we develop new medication to deal with it. Our promising early outcomes recommend that zoliflodacin might be considered one of them.”

Based on the CDC, gonorrhea is the second mostly reported notifiable illness in the US. In 2017, a complete of 555,608 instances of gonorrhea had been reported in the US. Louisiana ranks second within the nation with 257 instances per 100,000 individuals reported final yr. Infections resulting from Neisseria gonorrhoeae are a serious reason behind pelvic inflammatory illness (PID) in the US. PID can result in severe outcomes in girls, similar to tubal infertility, ectopic being pregnant, and power pelvic ache. As well as, epidemiologic and biologic research present proof that gonococcal infections facilitate the transmission of HIV an infection.

November 09, 2018

Yupelri is a long-acting muscarinic antagonist (LAMA)

The Food and Drug Administration (FDA) has approved Yupelri (revefenacin; Theravance and Mylan) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Yupelri is a long-acting muscarinic antagonist (LAMA); bronchodilation following inhalation of revefenacin is predominantly a site-specific effect. The product is intended for once-daily inhalation by a standard jet nebulizer connected to an air compressor. 

Yupelri was evaluated in 2 dose-ranging trials, 2 replicate 12-week, Phase 3 confirmatory trials, and a 52-week safety trial. In the 2 replicate 12-week, Phase 3 placebo-controlled trials (N=1229), patients aged ≥40 years with moderate to very severe COPD were randomized to receive Yupelri 175mcg once daily or placebo. The primary endpoint was change from baseline in trough FEV₁ at day 85. 

Treatment with Yupelri showed significant improvement in lung function vs placebo. In Trial 1, the least square mean change in trough FEV₁ was 127mL and -19mL in the Yupelri and placebo groups, respectively (treatment difference 146, 95% CI, 103.7, 188.8). In Trial 2, the least square mean change in trough FEV₁ was 102mL and -45mL in the Yupelri and placebo groups, respectively (treatment difference 147, 95% CI, 97.0, 197.1). In addition, the peak FEV₁ (within the first 2 hours after dosing) improvement on day 1 vs placebo was 133mL and 129mL in Trials 1 and 2, respectively. 

In Trial 1, the St. Georges Respiratory Questionnaire (SGRQ) responder rate (defined as an improvement in score of ≥4 as threshold) on day 85 was 49% for the Yupelri arm vs 34% for placebo (odds ratio [OR] 2.11, 95% CI 1.14, 3.92). In Trial 2, the SGRQ responder rate was 45% vs 39%, respectively (OR  1.31, 95% CI, 0.72, 2.38). 

The most common adverse events reported with therapy were cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. 

Yupelri will be available as 175mcg/3mL solution in unit-dose vials packaged in 30-count cartons. 

For more information call (877) 446-3679 or visit Mylan.com.

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