Target $15
Monday, June 10, 2019
NovaBay triples with Avenova available on Amazon without prescription
Shares of NovaBay Pharmaceuticals Inc. NBY, +211.32% more than tripled in very active premarket trade Monday, after the biopharmaceutical company said its Avenova eye-care product is now available without a prescription on Amazon.com AMZN, +2.24% through its new direct-to-consumer online channel. Avenova is a lid and lash spray, designed to remove bacteria and debris on and around the eyelid margin. The stock rocketed 262% on volume of 1.1 million shares, to make it the most actively traded ahead of the open. “While prescription Avenova continues to be available through retail pharmacies and direct in-office sales by certain eye care specialists, patients and physicians have asked for greater accessibility to the product,” said NovaBay Chief Executive Justin Hall. “In response, we are launching our new U.S. direct-to-consumer channel, which is a significant step in ensuring easy access at an affordable price.” The stock had tumbled 59% year to date through Friday, while the S&P 500 SPX, +0.71% has gained 15%.
ADA: Insulet sees gains in Type 1 diabetes with tubeless insulin pump in children
nsulet presented new data evaluating the use of its tubeless, closed-loop Omnipod insulin management system in young children with Type 1 diabetes.
Using an investigational version of the device, 14 children between the ages of two and six were supervised for over a week in a hotel to simulate the unique challenges of an at-home setting for this age group.
Following seven days of standard therapy with continuous glucose monitoring, the participants entered a two- to three-day treatment phase using the Omnipod’s personalized, predictive algorithms. During this second phase, meals were not restricted, and boluses were given according to the patient’s usual routine. Additionally, the participants exercised for more than 30 minutes per day.
Over a 24-hour period, average blood glucose levels were significantly lower during treatment with the closed-loop Omnipod device, with patients spending 32% more time in range. Similarly low glucose levels were seen overnight, while the patients slept, with 47% more time spent in range.
According to Insulet, the safety and performance of its Omnipod system was similar to that observed in older pediatric, adolescent and adult study participants. One severe hypoglycemic event was reported following exercise, which was treated with oral carbohydrates.
The results were presented at the annual Scientific Sessions of the American Diabetes Association in San Francisco alongside additional abstracts examining Insulet’s tubeless Omnipod device, including the real-world treatment patterns of thousands of adult and pediatric users as well as its use in combination with Glooko’s cloud-based diabetes data platform.
An observational study of more than 9,900 young pediatric and adolescent patients with Type 1 diabetes saw frequent bolusing with the Omnipod system and Glooko software, 5.3 times per day on average among users between the ages of 12 and 18. Between ages six and 11, that number increased to 6.4, and up to 7.5 among children under age six. Overall, the youth cohort data showed that blood glucose levels with a tubeless insulin pump compared favorably to those seen in larger Type 1 diabetes registries, the company said.
Similar results were seen in a separate analysis of about 8,000 adults with Type 1 diabetes with an average age of 40.8. There was an average of 4.7 bolus deliveries per day, with an average amount of 4.5 units of insulin each.
Sunday, June 9, 2019
Big global study: Diabetes med cuts cardiovascular and kidney problems
A clinical trial that followed more than 9,900 people in 24 countries has found that the drug dulaglutide reduced cardiovascular events and kidney problems in middle-aged and older people with Type 2 diabetes.
During more than five years of follow-up, cardiovascular events like heart attacks and strokes were reduced by 12% in people taking dulaglutide compared to people taking a placebo. This effect was seen in both men and women with or without previous cardiovascular disease.
In addition, during the same period, the drug reduced the development of kidney disease by 15%.
The trial was led by the Population Health Research Institute (PHRI) of McMaster University and Hamilton Health Sciences. Two papers describing the cardiovascular and kidney results of the trial were published today in the journal The Lancet from the study called the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial.
“Compared to others, people with diabetes have twice the rate of cardiovascular events like heart attacks and strokes, and up to 40% of people with diabetes develop kidney disease,” said Hertzel C. Gerstein, principal investigator for the study, professor of medicine at McMaster and deputy director of the PHRI.
“The REWIND trial shows that dulaglutide can safely reduce these events while improving diabetes control and modestly lowering weight and blood pressure in middle-aged people with Type 2 diabetes.”
Nearly one in five people over the age of 60 have diabetes and most have Type 2 diabetes. Altogether, nearly ten per cent of adults are living with diabetes, including 425 million people worldwide; 100 million in the U.S., and three million people in Canada.
Dulaglutide is a glucagon-like peptide-1 receptor agonist that is injected once per week. It is approved for glucose lowering and works by helping the pancreas release the right amount of insulin when blood sugar levels are high, slowing the emptying of the stomach after a meal, and reducing appetite and weight.
Gerstein pointed out the trial participants were very similar to the sorts of people with diabetes who are seen in medical practice. Participants were followed for a median of 5.4 years, much longer than previous trials, and more than 46 per cent of participants were women. Less than a third of participants had previous cardiovascular disease.
The drug was well tolerated, modestly reduced weight, low-density lipoprotein (LDL) cholesterol and blood pressure, and modestly increased heart rate. Gastrointestinal side effects including constipation or diarrhea were reported more frequently in participants taking dulaglutide (47%) compared to placebo (34%).
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The REWIND trial was funded by Eli Lilly and Company, the makers of the dulaglutide drug Trulicity. The study was designed and led by a team of scientists that included representatives of the funder. The data were analyzed by scientists of the PHRI and the principal investigator had final responsibility for the papers.
Lilly’s ultra rapid lispro provided similar A1C reductions compared to Humalog
Two phase 3 studies show that Eli Lilly and Company’s (NYSE: LLY) ultra rapid lispro (URLi) provided non-inferior A1C reductions compared to Humalog® (insulin lispro) at 26 weeks in people with type 1 and type 2 diabetes. The data from these treat-to-target studies showed URLi also significantly reduced the rise in blood glucose one hour and two hours after a test meal compared to Humalog.1,2 Additional data from the study in people with type 1 diabetes demonstrated URLi significantly improved glucose time in range during the day.3 URLi is an investigational novel mealtime insulin formulation being developed to better manage blood glucose levels. These data and several other studies were presented at the American Diabetes Association’s®79th Scientific Sessions®.
The two phase 3 studies, PRONTO-T1D and PRONTO-T2D, evaluated the safety and efficacy of URLi compared to Humalog in adults with type 1 and type 2 diabetes, respectively. Both studies met the primary endpoint of non-inferior A1C reduction from baseline compared to Humalog at 26 weeks, when the insulins were dosed at mealtime. Further, URLi demonstrated superior reduction in blood glucose spikes at both one hour (-27.9 mg/dL [T1D], -11.8 mg/dL [T2D]) and two hours (-31.2 mg/dL [T1D] and -17.4 mg/dL [T2D]) after a test meal compared to Humalog.1,2
Hypoglycemia is the most common adverse reaction associated with insulin. The studies showed no significant difference in severe, nocturnal or overall hypoglycemia rates reported by study participants.1,2
‘Many people taking mealtime insulin are not meeting their A1C goals while also experiencing high blood glucose levels after eating. This may create worry about their ability to achieve good control,’ said Bruce Bode, MD, FACE, diabetes specialist at Atlanta Diabetes Associates.4 ‘The results from these two studies suggest that URLi may help control blood glucose after meals, as well as help people reach A1C goals.’
The PRONTO studies were designed as treat-to-target, which enables clinicians to determine differences in other important treatment effects – such as rates of hypoglycemia, post-meal glucose control and glucose time in range – at the same level of glycemic control. A sub-set of participants in PRONTO-T1D were evaluated using blinded continuous glucose monitoring to provide more complete information on daily blood glucose patterns. At 26 weeks, URLi demonstrated a significantly better blood glucose profile up to four hours after breakfast compared to Humalog. The study further showed that URLi had significantly longer (+43.6 minutes) time in range (71-180 mg/dL) during the day and similar time in range during the night compared to Humalog.3
Data from a phase 1 clinical pharmacology study in people with type 1 diabetes also demonstrated URLi’s effect on post-meal blood glucose control. Results showed URLi was absorbed significantly faster into the blood stream compared to Humalog, insulin aspart and fast-acting insulin aspart. URLi also showed lower blood glucose spikes after a test meal compared to the insulins tested, which was significant compared to Humalog and insulin aspart. Additionally, the early blood glucose profile with URLi closely matched that of participants without diabetes.5
‘We’re developing URLi to provide a mealtime insulin option that more closely mirrors the way insulin works in people without diabetes,’ said Tom Hardy, MD, PhD, senior medical director at Lilly. ‘If approved, URLi will offer a new mealtime insulin option that, in clinical trials, showed similar A1C reductions to Humalog with significant improvements in post-meal blood glucose after a test meal.’
Lilly submitted applications for URLi with regulatory authorities in Europe and Japan and plans to submit in the U.S. later this year.
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