The US Food and Drug Administration (FDA) approved several treatments in a variety of therapeutic areas in September, 2020. Among these approvals, 4 were in areas of particular interest to the nurse practitioner and physician assistant: pain management, type 2 diabetes, hormone deficiency, and juvenile idiopathic arthritis.

Qdolo for Pain Management

For patients who have not tolerated or have not been provided adequate analgesia from alternate treatment options, the FDA has approved Qdolo™ (tramadol hydrochloride oral solution; Athena Bioscience) to manage pain severe enough to require an opioid analgesic.1

Qdolo contains 5 mg/mL of tramadol hydrochloride, and is a clear, grape-flavored solution administered orally. Due to the addictive nature of opioids, the FDA stresses the importance of only prescribing Qdolo to patients for whom other treatment methods have failed.1

Trulicity for Type 2 Diabetes

Two additional dosage strengths, 3mg and 4.5mg, of Trulicity® (dulaglutide; Lilly) have been approved by the FDA to manage type 2 diabetes.2


Continue Reading

The approval follows an AWARD-11 trial that analyzed dulaglutide at 3 mg and 4.5 mg compared with dulaglutide 1.5 mg in 1842 adult patients with type 2 diabetes who were inadequately controlled on metformin. All doses were administered once per week. Study participants who were given higher doses of dulaglutide experienced significant decreases in HbA1c and weight.2 The most commonly reported adverse reactions were nausea, vomiting, diarrhea, and dyspepsia.2

Sogroya for Hormone Deficiency

As a once-weekly injection to replace endogenous growth hormones in adults with growth hormone deficiency, Sogroya® (somapacitan-beco; Novo Nordisk) has been approved by the FDA.

In a multicenter, double-blind,  placebo-controlled, active-controlled phase 3 REAL 1 trial in which 300 adults with growth hormone deficiency were randomized 2:1:2 to receive once weekly injections of Sogroya or placebo or daily somatropin for 34 weeks, Sogroya successfully reduced participants’ truncal fat percentage and normalized their insulin-like growth factor.3

Xeljanz for Juvenile Idiopathic Arthritis

To treat active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients aged 2 years and older, the FDA has approved Xeljanz® (tofacitinib; Pfizer).4 The approval follows a phase 3 study in which 225 patients aged 2 to 17 were randomized into 2 groups; 1 group received tofacitinib and the other received a placebo. Patients who received tofacitinib experienced fewer disease flare-ups, and the medicine’s safety was comparable to what researchers had previously seen in adult patients.4

Though Xeljanz is currently supplied as 5-mg and 10-mg tablets, researchers hope to have a 1 mg/ml oral solution available by the first quarter of 2021.4

References

  1. Qdolo [package insert]. Athens, GA: Athena Bioscience, LLC; 2020.
  2. FDA approves additional doses of Trulicity® (dulaglutide) for the treatment of type 2 diabetes [news release]. Eli Lily & Co; September 3, 2020. Accessed October 13, 2020.  https://www.prnewswire.com/news-releases/fda-approves-additional-doses-of-trulicity-dulaglutide-for-the-treatment-of-type-2-diabetes-301124206.html. .
  3. FDA approves weekly therapy for adult growth hormone deficiency [news release]. US Food & Drug Administration; September 1, 2020. Accessed October 13, 2020. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-weekly-therapy-adult-growth-hormone-deficiency.
  4. US FDA approves Pfizer’s Xeljanz® (tofacitinib) for the treatment of active polyarticular course juvenile idiopathic arthritis [news release]. Business Wire; September 28, 2020. Accessed October 13, 2020. https://www.businesswire.com/news/home/20200928005729/en/U.S.-FDA-Approves-Pfizer%E2%80%99s-XELJANZ%C2%AE-tofacitinib-for-the-Treatment-of-Active-Polyarticular-Course-Juvenile-Idiopathic-Arthritis.