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Inveltys Accepted for Publish-Op Ache, Irritation After Ocular Surgical procedure

Posted in News on 27th August 2018
Inveltys is the first ocular steroid approved for twice-daily dosing for this indication

Inveltys is the first ocular steroid approved for twice-daily dosing for this indication

Kala announced that the Food and Drug Administration (FDA) has approved Inveltys (loteprednol etabonate) 1% ophthalmic suspension for the treatment of post-operative inflammation and pain following ocular surgery. 

Inveltys is the first ocular steroid approved for twice-daily dosing for this indication; other ocular steroids are approved for 4 times daily dosing. Inveltys utilizes the Company’s proprietary Mucus-Penetrating Particle (MPP) technology to improve penetration into target tissues of the eye. The technology has demonstrated a greater delivery of the drug into ocular tissues vs current loteprednol etabonate-containing drugs. 

Data from two Phase 3, multicenter, randomized, double-masked, placebo-controlled trials showed a greater proportion of patients treated with Inveltys having complete resolution of ocular inflammation at Day 8 (24% vs 13%) and Day 15 (50% vs 27%), and complete resolution of pain at Day 4 (43% vs 25%), Day 8 (56% vs 36%), and Day 15 (69% vs 48%) vs placebo (P for both <.01). In addition, treatment was well-tolerated with no treatment-related serious adverse events reported. 

Inveltys will be available as a 1% suspension in 5mL bottles. It is anticipated to launch in the beginning of 2019.

Viagra in being pregnant trial stopped after 11 new child infants died

Posted in News on 1st August 2018

A Dutch clinical trial was looking at the potential of Sildenafil or impotence drug Viagra to improve the growth in unborn babies of pregnant women. The study had to be stopped prematurely after the death of eleven babies.

Sildenafil is capable of improving the blood flow. In the clinical trial the team of researchers tried to use the drug to improve the blood flow to the placenta of the pregnant women. These participating pregnant women had poorly developed placenta that caused retardation of overall growth in the fetus. However when administered with Viagra the babies died because the drug causes fatal damage to the lungs of these unborn babies. A detailed investigation is underway to examine the cause of the deaths. Meanwhile authorities have stated that there has been no wrong doing in the trials.

There have been earlier smaller clinical trials in Australia, New Zealand and UK where Viagra had been administered to pregnant women with poorly developed placenta and fetal growth retardation. No harm was seen to the participating mothers in those studies. However Viagra failed to provide any extra benefits in these mothers. Thus in 2010 it was felt that the drug in these scenarios should be used only in clinical trials.

At present there are no treatments for fetal growth retardation due to poorly developed placenta in the mother. These babies are usually born prematurely and have a low birth weight. They have a poor chance of survival. This trial was an attempt to develop a medication that could prolong the gestational period till the baby is well grown and increase the body weight of the baby. This medication could save lives, felt the researchers.

For this study the Dutch researchers included participants who would be recruited for the study up until 2020 and the study would be carried out in 11 hospitals in the Netherlands, one of which is the Amsterdam University Medical Centre. The study began in 2015 and a speculated 350 patients were to be recruited. For this phase of the study 93 women were included and they were all administered Sildenafil. Another 90 women were included in the trial as controls and they were given a placebo drug or dummy.
After delivery it was noted that twenty babies developed lung complications. Of these three were in the placebo group and 17 were from the Sildenafil treated group. Eleven of the sick babies in the sildenafil group died of the lung complications. Eight other babies in the sildenafil treated group died of unrelated complications. Of the three babies in the placebo group that developed lung complications, none succumbed to the illness. Nine babies in the placebo group died due to unrelated causes. An independent committee looked at the study outcome and last week the study was terminated prematurely.

Prof Zarcko Alfirevic, from the University of Liverpool, was part of the UK team. He said that this result from the Dutch study is “unexpected” and more is to be found on the underlying mechanism of the deaths in the babies. “It needs a thorough investigation because the complications were not seen in the two other, similar trials that have already been done in the UK and Australia and New Zealand,” he said.

Wessel Ganzevoort, lead researcher and a gynaecologist said that the last thing they wanted is to harm the patients and they are shocked with the results. He said that their team has informed Canadian researchers who are conducting a similar study and instructed them to stop their research.


Posted in: Drug Trial News

Tags: Baby, Birth Weight, Blood, Clinical Trial, Impotence, Lungs, Newborn, Placebo, Placenta, Pregnancy, Research

Coronary heart Meds Recalled After Discovery of Attainable Carcinogenic Impurity

Posted in News on 17th July 2018
Not all valsartan-containing medications are part of this recall

Not all valsartan-containing drugs are a part of this recall

A number of drugs containing the energetic ingredient valsartan are being recalled after the Meals and Drug Administration (FDA) introduced that these medicine comprise N-nitrosodimethylamine (NDMA), an impurity categorised as a possible human carcinogen. 

The recalled drugs embrace Valsartan Tablets manufactured by Main Prescription drugs, Solco Healthcare, and Teva Prescription drugs, in addition to Valsartan/Hydrochlorothiazide Tablets from Solco Healthcare and Teva Prescription drugs. “We have now fastidiously assessed the valsartan-containing drugs offered in the US, and we have discovered that the valsartan offered by these particular firms doesn’t meet our security requirements,” mentioned Janet Woodcock, MD, director of the FDA’s Heart for Drug Analysis and Analysis. “For this reason we have requested these firms to take instant motion to guard sufferers.” 

As valsartan is used to deal with numerous cardiovascular situations together with coronary heart failure and hypertension, sufferers ought to proceed to take their drugs till they’ve a substitute product. Not all valsartan-containing drugs are a part of this recall; sufferers ought to contact the pharmacy that distributed the remedy to see if the drug got here from lots particularly manufactured by an organization talked about above.

Healthcare professionals are urged to report any potential unwanted effects associated to this recall to the FDA’s MedWatch Program. Within the meantime, the Company plans to proceed its investigation into the potential results NDMA might need on sufferers who’ve been taking these merchandise. Addressing a potential scarcity due the recall, FDA Commissioner Scott Gottlieb, MD, mentioned “As we search the removing of sure drug merchandise at this time, our drug shortages crew can also be working onerous to make sure sufferers’ therapeutic wants are met in the US with an ample provide of unaffected drugs.”

Honey + Sucralfate Might Cut back Damage After Unintentional Button Battery Ingestion

Posted in News on 12th June 2018

June 11, 2018

More studies are needed to establish the right amount and frequency of treatment

Extra research are wanted to ascertain the correct quantity and frequency of remedy

Early and frequent ingestion of honey + sucralfate might scale back esophageal harm in kids after unintended button battery ingestion, in response to a brand new research revealed in The Laryngoscope.

Noting that infants and youngsters who ingest button batteries can expertise esophageal injury resulting in important morbidity and dying in as little as 2 hours, researchers from the Youngsters’s Hospital of Philadelphia and Nationwide Youngsters’s Hospital aimed to determine efficient choices for mitigating these results by testing widespread weakly acidic family drinks, viscous liquids, and sucralfate (Carafate).

The research authors first examined apple juice, orange juice, Gatorade, Powerade, pure honey, pure maple syrup, and sucralfate utilizing a Three-volt lithium (Three V-CR2032) button battery on cadaveric porcine esophagus. From there, probably the most promising brokers had been in contrast in opposition to a saline management in reside piglet fashions with battery placement on the posterior wall of the proximal esophagus for 1 hour. The animals acquired 10mL irrigations each 10 minutes ranging from the 5-minute timepoint. 

Histologic and gross assessments confirmed that honey and sucralfate conferred probably the most safety in vitro and in vivo. Each brokers neutralized the elevated pH of the tissue and “created extra localized and superficial accidents.” A lower in each full-thickness harm and outward extension of harm was additionally famous (P <.05). 

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“Our suggestion can be for folks and caregivers to present honey at common intervals earlier than a baby is ready to attain a hospital, whereas clinicians in a hospital setting can use sucralfate earlier than eradicating the battery,” acknowledged co-principal investigator Ian N. Jacobs, MD. “Safely ingesting any quantity of those liquids previous to battery elimination is best than doing nothing.” 

The authors be aware that extra research are wanted to ascertain the correct quantity and frequency of remedy. In addition they warning in opposition to the usage of these substances in kids who’ve suspected sepsis, esophageal perforation, identified extreme allergy to honey or sucralfate, or in kids beneath 1 12 months of age as a result of a threat of botulism.

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New trial to check if omega-Three capsules can cease secondary liver most cancers recurrence after surgical procedure

Posted in News on 1st June 2018

A brand new scientific trial from the College of Leeds is testing omega-Three capsules in sufferers who’ve bowel most cancers which has unfold to the liver, to see if it could possibly cease the most cancers returning after surgical procedure.

Promising leads to an earlier smaller trial confirmed that offering sufferers with 2g per day of the omega-Three, known as EPA, for round a month previous to surgical procedure led to a 30 % enhance in survival after 18 months.

Researchers on the College of Leeds are constructing on this previous work by launching a bigger scientific trial, recruiting 450 sufferers who’re present process surgical procedure for bowel most cancers which has unfold to the liver, often known as secondary liver most cancers. The primary Leeds affected person has simply been recruited to the trial in Leeds Instructing Hospitals NHS Belief.

The trial is investigating whether or not a extremely purified type of the omega-Three EPA may very well be an efficient solution to cease most cancers returning after surgical procedure, and is funded by Yorkshire Most cancers Analysis.

Professor Mark Hull, from the College of Leeds’ Institute of Biomedical and Medical Sciences and Leeds Instructing Hospitals, is main the trial, which entails a number of hospitals from across the nation, together with Leeds, Sheffield and Southampton.

Professor Hull mentioned: “Secondary liver most cancers is the main reason for demise for sufferers with bowel most cancers, because the most cancers spreads from the bowels to the liver, so it’s vitally necessary that we enhance our capacity to cease secondary liver unfold.

“After present process surgical procedure to take away secondary liver most cancers, 50 to 75 % of sufferers develop a recurrence of the illness after two years, so we’re investigating an intervention which will assist cease the most cancers returning.

“Given the minimal side-effects of omega-Three capsules and the way comparatively cost-effective they’re in contrast with different dearer anti-cancer therapies, this intervention might in the future be used broadly to enhance survival from superior bowel most cancers.”

Bowel most cancers is the fourth most typical most cancers within the UK, with greater than 41,000 new instances identified yearly.

Whereas survival has greater than doubled within the final 40 years, greater than half of sufferers with the illness expertise recurrence elsewhere within the physique, mostly the liver or lungs, which is called secondary, superior or metastatic bowel most cancers.

Omega-Three fatty acids are discovered primarily in fish oils and are already identified to be helpful for different well being situations together with coronary heart issues.

Dr Kathryn Scott, Chief Govt at Yorkshire Most cancers Analysis which is funding the trial, mentioned: “It is a low-cost and doubtlessly highly effective new means to assist deal with bowel most cancers that, if profitable, might have a huge effect.

“In addition to having a possible influence on therapy, the trial will present a chance for sufferers to participate in a pioneering examine. It’s nicely confirmed that sufferers do higher in a research-rich atmosphere.”

The EPA formulation, often known as icosapent ethyl and marketed as a prescription product known as Vascepa® in the US, and the placebo, have been donated freed from cost by Amarin Company plc.