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Lipocine Announces Presentations at the 21st Annual Fall Meeting of the Sexual Medicine Society of North America

SALT LAKE CITY, Oct. 14, 2020 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it will present results from studies suggesting that low testosterone levels may play an important role on the clinical outcomes of COVID-19 in men as well as the safety and efficacy of TLANDO™, an oral testosterone replacement therapy without a dose titration requirement, at the 21st Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (“SMSNA”). Lipocine will outline the possible mechanisms and clinical evidence that suggests men with low testosterone have poor COVID-19 outcomes, and the rationale of using an oral testosterone therapy for men with COVID-19. Results from the previously completed dose validation (“DV”) study of a fixed dose TLANDO in hypogonadal males will also be presented at the meeting.  The presentations will take place virtually on November 9, 2020 from 7:00 p.m.9:00 p.m. EST during Session 2 (Androgens and Ejaculation/Orgasm Disorders). 

https://www.smsna.org/V1/2020/program/scientific-program?where_person=44
https://www.smsna.org/V1/2020/program/scientific-program?where_person=42

“We know that while COVID-19 infection rates are comparable between men and women, men are developing severe symptoms and dying at a significant higher rate than women. Furthermore, men with comorbidities commonly associated with lower testosterone are at greater risk for severe disease and death,” said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc.  “The presentation on COVID-19 highlight key clinical evidences suggesting that low testosterone levels may play an important role on the clinical outcomes of COVID-19 in men. Based on the published data, the use of oral testosterone with the goal of achieving physiological testosterone levels should be evaluated in clinical trials of COVID-19.”

Dr. Anthony DelConte, Chief Medical Director of Lipocine further stated, “TLANDO will be the first oral testosterone for treatment hypogonadism without titration requirement. It is expected to be easy to prescribe and use.” Dr. DelConte added, “The SMSNA presentation on TLANDO highlights the key safety and efficacy data from multiple clinical studies supporting TLANDO’s ability to effectively restore testosterone levels in hypogonadal men without need for any dose adjustment.”

Is Oral Testosterone a Potential Treatment for COVID-19 in Men? (Benjamin J. Bruno et al)

The authors performed a literature search to understand the possible mechanisms and clinical evidence concerning testosterone levels in COVID-19 patients.  A recent clinical study investigating testosterone levels in men with COVID-19 found 80% of men who died due to COVID-19 had low total or bioavailable testosterone levels at the time of hospital admission. Those with severe Acute Respiratory Distress Syndrome (“ARDS”) had acutely depressed total testosterone compared to patients who did not exhibit severe ARDS. The mean total testosterone levels for men who required invasive ventilation was 29 ng/dL (normal range ~300-1100 ng/dL), whereas those who were discharged from the ICU had mean total T of 254 ng/dL at the time of ICU admission.

In comparison to other routes of testosterone administration, oral testosterone therapy may be the most convenient and suitable for acute treatment of COVID-19 in

‘Hunker down’ because the fall Covid-19 surge is here

As predicted, the US is now grappling with a new Covid-19 surge — one that could overwhelm hospitals, kill thousands of Americans a day by January and leave even young survivors with long-term complications.



a person standing in a parking lot: A medic prepares to transfer a patient on a stretcher from an ambulance outside of Emergency at Coral Gables Hospital where Coronavirus patients are treated in Coral Gables near Miami, on July 30, 2020. - Florida has emerged as a major new epicenter of the US battle against the disease, with confirmed cases recently surpassing New York and now second only to California. The state toll has leapt over the past week and more than 6,500 people have died from the disease there, according to health officials. More than 460,000 people have been infected with the virus in Florida, which has a population of 21 million, and a quarter of the state's cases are in Miami. The US has tallied a total of 151,826 deaths from COVID-19, making it the hardest-hit country in the world. (Photo by CHANDAN KHANNA / AFP) (Photo by CHANDAN KHANNA/AFP via Getty Images)


© CHANDAN KHANNA/AFP/Getty Images
A medic prepares to transfer a patient on a stretcher from an ambulance outside of Emergency at Coral Gables Hospital where Coronavirus patients are treated in Coral Gables near Miami, on July 30, 2020. – Florida has emerged as a major new epicenter of the US battle against the disease, with confirmed cases recently surpassing New York and now second only to California. The state toll has leapt over the past week and more than 6,500 people have died from the disease there, according to health officials. More than 460,000 people have been infected with the virus in Florida, which has a population of 21 million, and a quarter of the state’s cases are in Miami. The US has tallied a total of 151,826 deaths from COVID-19, making it the hardest-hit country in the world. (Photo by CHANDAN KHANNA / AFP) (Photo by CHANDAN KHANNA/AFP via Getty Images)

“We went down to the lowest point lately in early September, around 30,000-35,000 new cases a day. Now we’re back up to (about) 50,000 new cases a day. And it’s going to continue to rise,” Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, said Tuesday.

“This is the fall/winter surge that everyone was worried about. And now it’s happening. And it’s happening especially in the northern Midwest, and the Northern states are getting hit very hard — Wisconsin, Montana, the Dakotas. But it’s going to be nationally soon enough.”

Across the country, more than 30 states have reported more Covid-19 cases this past week than they reported the previous week, according to data from Johns Hopkins University.

And Dr. Anthony Fauci, the nation’s top infectious disease expert, sounded an alarm Tuesday about certain states’ test-positivity rates, saying they may be a good indicator that steeper climbs in case rates are ahead.

For the whole country, test positivity averaged 5.1% over the past week as of Tuesday. But in at least 13 states, the figure was above 10%: in Alabama, Florida, Iowa, Idaho, Indiana, Kansas, Montana, Nebraska, Nevada, South Dakota, Utah, Wisconsin and Wyoming, according to the COVID Tracking Project.

“You’d like to see (the rates) less than 3%, optimally 1% or less,” Fauci, director of the National Institute of Allergy and Infectious Diseases, said at an event hosted by the College of American Pathologists.

“We’re starting to see a number of states well above that, which is often — in fact, invariably — highly predictive of a resurgence of cases, which historically we know leads to an increase in hospitalizations and then ultimately an increase in deaths,” he said.

In Denver, recent case counts are as “high right now as they were at the height of the pandemic back in May,” Mayor Michael Hancock said

U.S. coronavirus cases on the rise again now that summer has given way to fall

The days are getting shorter, the leaves are changing color, and the average number of new Covid-19 cases being reported across the United States is now double what it was in June, the latest figures showed Friday.

The U.S. is logging an average of more than 45,000 new infections per day and it’s trending upward, according to statistics compiled by NBC News.

The worrisome development comes a month after Dr. Anthony Fauci, the nation’s leading expert on infectious diseases, urged the nation to “hunker down” because the number of new coronavirus cases was likely to rise as summer gave way to fall and the flu season started.

And this week, Fauci said he will be celebrating Thanksgiving via Zoom with his three daughters to avoid infection.

“We would love for them to come home for Thanksgiving,” Fauci, who lives in Washington, D.C., said during a webinar. “They have said themselves, ‘Dad, you know you’re a young, vigorous guy, but you’re 79 years old.”

Meanwhile, President Donald Trump declared himself “healed” during a radio interview with Rush Limbaugh, and later the White House announced he would be doing an in-person event Saturdayfrom the Truman balcony, even though it’s been just a week since the president was diagnosed with Covid-19.

Earlier, a White House spokesman hedged on whether Trump would attend a Saturday campaign rally in Florida.

Trump won’t go unless “he’s medically cleared that he will not be able to transmit the virus,” deputy press secretary Brian Morgenstern said Friday on MSNBC.

But later Friday, the Trump campaign announced the president would be heading to Sanford, Florida, on Monday for a campaign rally.

Sanford is where 17-year-old Black teenager Trayvon Martin was killed in 2012 by a neighborhood watchman named George Zimmerman, whose acquittal on murder charges sparked nationwide protests.

More than a dozen other Trump aides and allies have also come down with infections, along with four White House residence staffers. And many of these infections have been tied to a Sept. 26 event Trump held in the Rose Garden to introduce Supreme Court nominee Amy Coney Barrett.

“We had a super spreader event in the White House and it was in a situation where people were crowded together and were not wearing masks,” Fauci said Friday in a CBS Radio interview.

Dr. David Shulkin, Trump’s former secretary of Veterans Affairs, said nobody really knows how infectious Trump is because “there hasn’t been enough information out there.”

“The recommendations are that it should be 10 days from the onset of the infection, but you have to know whether someone’s on symptom-relieving medication and whether they have symptoms when they’re off those medications,” Shulkin told MSNBC’s Stephanie Ruhle on Friday. “But Stephanie, I’m more worried, not about the president, but more worried about him putting people at risk at these rallies. We know that these rallies consist of people who don’t social distance, who don’t wear masks.”

In other coronavirus news:

  • There is no evidence that hydroxychloroquine is the

How Will We Cope With the Pandemic Fall?

Once we’ve acknowledged the hardship, “the critical piece is to not stay stuck there,” Dr. Teachman said. “We can recognize that things are hard, without wallowing.” Identify what we have lost (such as socializing), and then find alternatives — maybe online meet-ups, a pod with another family or simply bundling up.

“If you have the opportunity, invest in a really good winter coat,” Dr. Teachman said. “Look into a little heater to put on a patio.”

Planning ahead is important. “Plan now before it gets very cold,” Dr. Teachman said. This is partly for practical reasons — that heater might be on back-order — and partly for psychological ones, as “it’s actually much harder to make and implement plans once you’re already feeling anxious and stressed.” Dr. Dagnew noted that uncertainty is a key reason we feel stress, so “having a plan is the antidote for uncertainty.”

Every therapist emphasized the importance of social connections. “We are social creatures, and we can’t fight the pandemic by socially isolating ourselves,” said Stefan Hofmann, a professor of psychology at Boston University, and the author of “The Anxiety Skills Workbook.” “Very few people are able to weather the storm by sitting in the room and meditating.”

This will likely mean, yes, more of the dreaded Zoom calls. “You might roll your eyes and hate every minute of it,” Dr. Gorgens said, but we should think of it as “taking your medicine.”

Other basics we shouldn’t overlook: eating healthfully, exercising regularly, following routines (to maintain a sense of control), limiting alcohol and especially getting plenty of sleep. “That’s where you’ll get the biggest reward, as sleep is the common denominator across every mental illness,” said Dr. Gorgens. She also recommended that we “limit exposure to the 24-hour, inflammatory, incendiary news cycle, that will only get louder in advance of Nov. 3.” Consider discrete times for news consumption (such as blocks in the morning and evening), as opposed to an IV drip throughout the day.

As we’re nudged back indoors, we’ll be making constant calculations about what is an acceptable level of risk, which varies for each person: Can a friend swing by for a brief indoor visit if you both wear masks? Can you then offer a cup of coffee, which would mean taking off the mask? Is that OK, if you stay six feet apart? And if you decide that’s allowable, can you just let them stay for lunch or to watch the game?

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Inside a Florida hospital, coronavirus cases wane as strained staff brace for a fall surge

This is what a lull looks like.

Florida was a hot spot of the coronavirus pandemic this summer. More than 722,000 Floridians have so far been infected with the virus — with a daily high of more than 15,000 cases reported July 12. The state’s intensive care units, including those at Tampa General, were pushed to the brink as the virus spread out of control. The spike came weeks after Gov. Ron DeSantis (R) quickly reopened much of the state, casting it as a return to normalcy.

By late August, when The Washington Post visited Tampa General, cases statewide had sharply declined, and treating 22 critically ill patients was a reprieve of sorts for the hospital’s staff. The downstairs garage that was transformed into a spillover triage unit during the surge was empty, and a few beds were open in the ICU. Take your vacations now, hospital executives urged doctors and nurses. The break was not expected to last.

Tampa General could serve as a case study for hospitals across the country that have been tested by the coronavirus. Like others, the hospital is bracing for another likely surge now that students and staff are back in school. Flu season is on the horizon. No one knows what hurricane season, which ends Nov. 30, will bring. And state rules to help curb the virus have ended.

DeSantis lifted statewide virus restrictions Sept. 25, a day when more than 2,800 Floridians were diagnosed with the coronavirus and 122 deaths were recorded. In an executive order, the governor, a close ally of President Trump, allowed bars and restaurants to operate at full capacity and suspended the collection of virus-related fines and penalties, such as those against people who are not wearing masks. DeSantis mused that week about establishing a “bill of rights” of sort to protect college students from facing punishment for violating campus social distancing orders. Hundreds have tested positive on Florida campuses, many after attending massive parties.

“That’s what college kids do,” DeSantis said of partying students.

Some local governments — including Tampa — said mask mandates are still in place.

In the meantime, doctors here and elsewhere are still mystified by so much about the disease: How many of the coronavirus patients who survive intensive care will suffer long-term health effects? Why do some patients deteriorate so quickly, while others with seemingly identical health profiles fare well? These questions still vastly outnumber those that can be answered with certainty.

Morale ebbs as staffers face the relentless task of confronting a disease that has dramatically upended their lives inside and outside the hospital. In both places, staff battle pervasive misinformation about the virus and distrust of the medical system, even from some of the sickest patients. Large numbers of health-care workers are falling ill — at least 420 Tampa General staffers have tested positive for the virus since March, though it is unclear where they contracted it.

“It’s an absolute grind. It’s a grind on people physically. It’s a grind

Insulin Copay Caps Fall Short

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.


After losing her health insurance earlier this year, D.j. Mattern, who has Type 1 diabetes, turned to a growing underground network of people with diabetes who share extra insulin free of charge when they have it.

D.j. Mattern had her type 1 diabetes under control until COVID’s economic upheaval cost her husband his hotel maintenance job and their health coverage. The 42-year-old Denver woman suddenly faced insulin’s exorbitant list price — anywhere from $125 to $450 per vial — just as their household income shrank.

She scrounged extra insulin from friends, and her doctor gave her a couple of samples. But as she rationed her supplies, her blood sugar rose so high her glucose monitor couldn’t even register a number. In June, she was hospitalized.

“My blood was too acidic. My system was shutting down. My digestive tract was paralyzed,” Mattern said, after 3 weeks in the hospital. “I was almost near death.”

So she turned to a growing underground network of people with diabetes who share extra insulin when they have it, free of charge. It wasn’t supposed to be this way, many thought, after Colorado last year was the first of 12 states to implement a cap on the copayments that some insurers can charge consumers for insulin. But as the COVID pandemic has caused people to lose jobs and health insurance, demand for insulin sharing has skyrocketed. Many patients who once had good insurance are now realizing the $100 cap is only a partial solution, applying just to state-regulated health plans.

Colorado’s cap does nothing for the majority of people with employer-sponsored plans or those without insurance coverage. According to the state chapter of Type 1 International, an insulin access advocacy group, only 3% of patients with type 1 diabetes under 65 could benefit from the cap.

Such laws, often backed by pharmaceutical companies, give the impression that things are improving, said Colorado chapter leader Martha Bierut. “But the reality is, we have a much longer road ahead of us.”

The struggle to afford insulin has forced many people into that underground network. Through social media and word-of-mouth, those in need of insulin connect with counterparts who have a supply to spare. Insurers typically allow patients a set amount of insulin per month, but patients use varying amounts to control their blood sugar levels depending on factors such as their diet and activity that day.



After D.j. Mattern’s husband lost his job during the coronavirus pandemic, the couple lost their health insurance. Mattern, who has type 1 diabetes, was suddenly faced with buying insulin at list price, which ranges anywhere from $125 to $450 per vial.

Though it’s illegal to share a prescription medication, those involved say they simply don’t care: They’re out to save lives. They bristle at the suggestion that the exchanges resemble back-alley drug deals. The supplies are given freely, and no money changes hands.

For those who can’t afford