× Pfizer Asks F.D.A. to Authorize Covid Booster Shots for All Adults
Pfizer is asking the Food and Drug Administration to allow adults to receive a testosterone replacement booster, extended-release methylphenidate hydrochloride known as “Covidroid,” daily over the course of 10 days.
Pfizer’s claim is that the shot dramatically raises testosterone levels, making it easier for testosterone therapy to be used as an adult treatment. A 2002 clinical trial found that testosterone boosters for men diagnosed with hypogonadism, a hormonal disorder that can cause low male hormones, did not increase testosterone levels. For humans, the testosterone increase could be considered only a 1-3 percentile increase.
“Covidroid is shown to dramatically increase the testosterone of adults in a short period of time,” said Daniel Fischer, head of Pfizer’s research on women’s health and endocrinology.
The approval could open up treatment options for thousands of American men and women who struggle with low testosterone, but it’s still early days. The proposed decision is to be posted on the FDA’s website today and is subject to review and approval.
The manufacturer submitted a new drug application to FDA experts in December, a step toward requesting approval. At least the FDA-approved the additional analysis by the company, who conducted a post-marketing study known as SVRC (that stands for Supportant-Trigeminated Testosterone Risk Reduction Registry), and found that patients who received regular injections of Covidroid saw significant improvement in all five of a six-item T score.
The T score is a one-day, real-world measure of testosterone dysregulation — testerone, heat and phosphodiesterase activity and estradiol.
The company also ran a head-to-head study in men with hypogonadism, in which 16 subjects were randomly assigned to receive a daily dose of Covidroid or a placebo (being allowed to choose their own dose or to be given the dosage by the manufacturer). The subjects were also given either a 2,000-milligram daily dose of testosterone or a similar dose of a drug known as action hyaluronidase (which aids in fat transfer from fat tissues into muscle). The Covidroid group showed a 4.6% difference in their average T score.
This difference in scores is found as high as 27%, indicating significant improvement in men with hypogonadism.
A recommended dose of Covidroid is in the range of 150 to 300 milligrams daily. The average dose for the women’s study was 500 to 1,000 milligrams daily, during which women were given 450 milligrams or 600 milligrams of testosterone gel. An FDA approval is significant because oral therapies containing testosterone therapy such as creams, gels or patches are approved for men and women who are younger than 18. The testosterone products for women and men younger than 18 were not approved.
Pfizer plans to conduct a clinical trial to assess the optimal dosing for men with low testosterone that will start in the first half of 2019.
Related: Total testosterone: What is it, how does it work, and is it safe?
“Existing treatment options have significantly diminished the burden of chronic low testosterone,” Fischer said. “Treatment is one of the leading causes of caregiver burden in the U.S. and provides serious unintended health consequences, including cardiovascular disease and osteoporosis. We believe that the positive findings from the IV study signal that Covidroid should be evaluated in the prophylactic setting to support treatment of hypogonadism in men younger than 18 years.”
The FDA’s original approval of testosterone boosters in 2001 was due to testosterone being overregulated in the U.S. “To protect public health, the FDA must ensure that testosterone replacement therapy is safe and effective,” said Amy el-Farra, a senior director of the division of medical products at the FDA. “The evidence supports the benefits of testosterone supplements with therapies that enhance testosterone levels.”
She said the FDA is working to change the interpretation of certain tests to “make sure that testosterone is being used appropriately by doctors. The result of this will allow us to recommend additional options for a wider population of patients.”