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Section 2 examine of ziresovir for treating hospitalized RSV contaminated infants achieves important progress

Posted in News on 3rd November 2018

Ark Biosciences, a biotech firm creating proprietary therapeutics for viral an infection and respiratory ailments, introduced in the present day the numerous progress in its part 2 proof-of-concept examine of ziresovir within the remedy of hospitalized RSV contaminated infants. The unblinded medical efficacy outcomes of half 1 of the part 2 examine will probably be introduced on the 11th Worldwide RSV Symposium to be held in Asheville, North Carolina and additional particulars on progress on the sixth Worldwide Society for Influenza and different Respiratory Viruses Antiviral Group Convention – Advances in Respiratory Virus Therapeutics – to be held in Washington DC, USA in November.

The anti-RSV drug ziresovir, a novel RSV F-protein inhibitor, was found by Roche scientists, and was licensed to Ark Biosciences in 2014. Ark Biosciences has accomplished a number of medical research with the compound, together with two part 1 medical research in wholesome grownup volunteers in Australia and China, a part 1 human mass steadiness examine in the UK. Ark has additionally been conducting a worldwide part 2 PoC medical trial of ziresovir entitled VICTOR (Viral Inhibition in Youngsters for Remedy of RSV). The examine is “A Randomised, Double-blind, Placebo-controlled, 2-Half Examine of Orally Administered AK0529 to Consider the Security, Tolerability, Pharmacokinetics and Antiviral Impact of Single and A number of Dosing in Hospitalized Infants with Respiratory Syncytial Virus An infection”. Within the examine ziresovir is being investigated for its security and medical efficacy in infants hospitalized for decrease respiratory tract an infection with naturally acquired RSV an infection.

“Now we have made an ideal progress within the medical improvement of ziresovir as first-line antiviral remedy for the remedy of RSV contaminated sufferers, particularly hospitalized infants, which is the place the best unmet medical want exists,” stated Dr Jim Z. Wu, founder and CEO of Ark Biosciences. “We stay up for sharing the promising security and medical efficacy information from our part 2 VICTOR examine with the medical neighborhood on the upcoming worldwide conferences.”

Dr Stephen Toovey, MD PhD, Chief Medical Officer of Ark Biosciences, commented that, “There is a gigantic want for brand new medicines to deal with the hundreds of thousands of pediatric and aged sufferers that suffer RSV an infection yearly. Within the accomplished first a part of the part 2 VICTOR examine for the remedy of infants hospitalized with RSV an infection, for the primary time ever, an antiviral agent, ziresovir, has demonstrated glorious security profile and a transparent dose-dependent medical efficacy, decreasing sufferers’ indicators and symptom scores. We stay up for reporting these thrilling medical leads to the upcoming 11th Worldwide RSV Symposium in Asheville and the sixth Worldwide Society for Influenza and different Respiratory Viruses Antiviral Group Convention – Advances in Respiratory Virus Therapeutics in Washington DC.”

With the event of ziresovir, Ark goals to be the trade chief in anti-RSV drug improvement, and to develop the first-in-disease anti-RSV drug to fulfill the extraordinarily massive unmet medical want posed by RSV an infection.

Supply:

http://www.arkbiosciences.com/

Dsuvia Accepted for Administration of Acute Ache in Healthcare Settings

Posted in News on 3rd November 2018

November 02, 2018

Dsuvia will not be available in retail pharmacies or for outpatient use

Dsuvia will not be available in retail pharmacies or for outpatient use

AcelRx announced that the Food and Drug Administration (FDA) has approved Dsuvia (sufentanil) sublingual tablets for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. It is not intended for use beyond 72 hours.

The sublingual formulation of sufentanil offers a new treatment option for patients with nothing by mouth (NPO) status and patients with difficult IV access (eg, obese, burn, elderly, needle-phobic patients) to manage acute pain. The single-unit packaging and single-strength sublingual tablets are intended to mitigate the possibility of dosing errors, misuse, and diversion. “Managing acute pain is critical to a patient’s recovery process, especially in the postoperative setting, but current oral and IV opioid analgesics can be slow-acting and challenging to dose and administer, which in turn can limit optimal pain relief and even be dangerous to patients,” said Dr. David Leiman, Clinical Assistant Professor of Surgery, University of Texas at Houston and Director of HD Research.

Dsuvia was evaluated in a randomized, double-blind, placebo-controlled study (N=161) involving patients with acute postoperative pain after abdominal surgery (studied up to 48hrs). Study patients were randomized to Dsuvia 30mcg or placebo as needed with dosing at least 60mins apart; IV morphine sulfate was available as rescue medication. 

The data showed a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared with placebo. The difference in pain intensity from baseline was superior to that of the placebo group within 15 minutes. Also, a smaller proportion of patients in the Dsuvia group took rescue medication within the first 12 hours of the treatment phase, as compared with the placebo group (22% vs 65%). Regarding safety, the most commonly reported adverse reactions were nausea, headache, vomiting, dizziness, and hypotension. 

In a statement, the FDA’s Commissioner Scott Gottlieb, MD, said, “The FDA will continue to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements, and we’ll work to quickly make regulatory adjustments if problems arise […] I believe that the unique aspects of Dsuvia, including those that make this drug a high priority for the Pentagon, differentiate this new formulation of sufentanil from other sufentanil products in a way that is consistent with population-based considerations for how it fits into the overall drug armamentarium.”

Dsuvia, a Schedule II substance, will be available as 30mcg strength sublingual tablets in a single-dose, pre-filled applicator for administration by a healthcare professional only in certified medically supervised settings. Distribution is expected in the first quarter of 2019 only to healthcare settings certified in the Dsuvia Risk Evaluation Mitigation Strategy (REMS) program. Dsuvia will not be available in retail pharmacies or for outpatient use.

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For more information call (650) 216-3500 or visit AcelRx.com.

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Quitting Zoloft (A Private Commentary)

Posted in Sertaline on 3rd November 2018

AstraZeneca to current Part III CVOT DECLARE-TIMI 58 outcomes at AHA Scientific Classes

Posted in News on 2nd November 2018

AstraZeneca will current 20 abstracts together with a late-breaking oral presentation on the total outcomes from the Part III cardiovascular (CV) outcomes trial (CVOT) DECLARE (Dapagliflozin Impact on Cardiovascular Occasions)-TIMI 58, the broadest SGLT2 inhibitor CVOT performed thus far, in addition to new analysis from the Firm’s Cardiovascular, Renal & Metabolism (CVMD) remedy space on the American Coronary heart Affiliation (AHA) Scientific Classes, November 10-12, 2018, in Chicago, Illinois, USA.

New proof will construct on broad scientific analysis from AstraZeneca that goals to assist redefine the administration of CVMD illnesses and handle the necessity for a extra proactive and holistic method to affected person care. Displays will embody findings from a number of the largest trials in broad affected person populations with FARXIGA (dapagliflozin) in kind 2 diabetes (T2D), BRILINTA (ticagrelor) in sufferers with a historical past of coronary heart assault, and in hyperkalemia.

Danilo Verge, Vice President, Cardiovascular, Renal & Metabolism, International Medical Affairs, mentioned: “An estimated 20 million individuals every year die from cardiovascular, renal and metabolic illnesses, but shared threat elements are steadily not recognized or addressed holistically. Our knowledge at AHA replicate an built-in method to managing the wants of sufferers residing with kind 2 diabetes and threat of cardiovascular or renal illness, and people with a historical past of heart problems at acute and long-term threat of recurrence. We stand firmly behind our mission to offer new options earlier in illness administration to those sufferers in danger for a number of problems.”

DECLARE-TIMI 58: a landmark CVOT evaluating CV threat in sufferers with T2D

Scientific trial outcomes exhibiting the protection and efficacy of FARXIGA vs. placebo on main CV and secondary renal efficacy outcomes in adults with T2D who’ve a number of CV threat elements or established CV illness, can be introduced in a late-breaking oral presentation (Late Breaking Summary #19485). DECLARE-TIMI 58 evaluated the CV outcomes of FARXIGA vs. placebo over a interval of as much as 5 years, throughout 33 international locations and in additional than 17,000 adults with T2D with a number of CV threat elements or established CV illness.

In September 2018, AstraZeneca introduced that FARXIGA met its main security endpoint of non-inferiority for main antagonistic cardiovascular occasions (MACE) and achieved a statistically-significant discount within the composite endpoint of hospitalization for coronary heart failure (hHF) or CV dying, one of many two main efficacy endpoints. Moreover, fewer MACE occasions have been noticed with FARXIGA for the opposite main efficacy endpoint, nevertheless, this didn’t attain statistical significance. Scientific trial outcomes introduced at AHA Scientific Classes 2018 will embody extra particulars on the first CV security and efficacy, in addition to secondary renal efficacy outcomes from DECLARE-TIMI 58. FARXIGA just isn’t indicated to cut back the chance of CV occasions, hHF or renal outcomes.

Three new sub-analyses from the PEGASUS-TIMI 54 trial can even be introduced. The trial in contrast BRILINTA (90mg or 60mg twice day by day) plus aspirin vs. aspirin alone in 21,162 sufferers with prior (1 to three years) coronary heart assault. The sub-analyses consider:

  • Whether or not scientific traits predicting bleeding and ischemic threat determine subgroups of sufferers who could derive profit from long-term therapy with BRILINTA, with a decrease threat of main bleeding (Poster #Sa2100)
  • The results of long-term use of BRILINTA in sufferers who’ve had a coronary heart assault and who didn’t obtain a coronary stent vs. those that did obtain a coronary stent placement (Oral Presentation #102)
  • The usage of high-sensitivity cardiac troponin to determine sufferers who’re at a higher-risk of main CV occasions (Oral Presentation #100)

Knowledge can even be introduced on potential threat elements for repeated or persistent hyperkalemia (Poster # SuMDP65).

Supply:

https://www.astrazeneca.com/media-centre/press-releases/2018/the-landmark-declare-timi-58-cardiovascular-outcomes-trial-of-farxiga-in-patients-with-type-2-diabetes-to-be-featured-at-aha-01112018.html

Posted in: Drug Trial Information | Medical Situation Information

Tags: Acute Kidney Harm, Angioedema, Aspirin, AstraZeneca, Autoimmunity, Biopharmaceutical, Bladder, Bladder Most cancers, Bleeding, Blood, Breastfeeding, Most cancers, Cardiovascular Illness, Ldl cholesterol, Scientific Trial, Clopidogrel, Creatinine, Diabetes, Diabetes Mellitus, Diabetic Ketoacidosis, Dialysis, Eating regimen, Medication, Dyspnea, Erythema, Train, Fever, Gangrene, Glucose, Coronary heart, Coronary heart Assault, Coronary heart Failure, Hyperkalemia, Hypersensitivity, Hypoglycemia, Hypotension, Insulin, Kidney, Life Expectancy, Lipoprotein, Metabolism, Mortality, Neuroscience, Oncology, Ache, Pancreas, Peptic Ulcer, Placebo, Being pregnant, Pyelonephritis, Renal illness, Analysis, Respiratory, Statin, Stent, Stroke, Surgical procedure, Thrombosis, Troponin, Sort 1 Diabetes, Sort 2 Diabetes, Ulcer

Epidiolex Now Obtainable to Deal with Seizures Related With LGS, Dravet Syndrome

Posted in News on 2nd November 2018

November 01, 2018

Epidiolex is supplied as a 100mg/mL strawberry-flavored oral solution

Epidiolex is supplied as a 100mg/mL strawberry-flavored oral solution

Epidiolex (cannabidiol oral solution) has been made available by GW Pharmaceuticals for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients ≥2 years old.

The Food and Drug Administration (FDA) approved the treatment in June 2018, making it the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol, as well as the first treatment indicated for patients with Dravet syndrome. The approval of Epidiolex was based on data from 3 randomized, double-blind, placebo-controlled trials involving patients with either LGS or Dravet syndrome. In September 2018, Epidiolex was rescheduled from a Schedule I substance to a Schedule V, the lowest restriction classification.

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Epidiolex is supplied as a 100mg/mL strawberry-flavored oral solution. The product is packaged with a calibrated measuring device and is recommended to measure and deliver the prescribed dose. Any unused portion of the medication should be discarded after 12 weeks of first opening the bottle.

Prior to starting treatment, patient serum transaminases (ALT and AST) and total bilirubin levels should be obtained because of the risk of hepatocellular injury. Food may affect levels of Epidiolex, therefore patients should be advised to take the drug consistently either in the fasted or fed state.

GW Pharmaceuticals has also launched the Epidiolex Engage support program to help patients and clinicians navigate the steps to obtaining Epidiolex; the program also provides education and resources to patients and caregivers.

“We are delighted to announce that Epidiolex is now available by physician prescription as a new treatment option for patients with LGS and Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy,” said Justin Gover, Chief Executive Officer of GW Pharmaceuticals. “We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”

For more information visit epidiolexhcp.com.

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