Acella Pharmaceuticals, LLC, and its sister company Neuvosyn Laboratories, LLC, today announced positive topline results from their Phase II randomized, double-blind controlled clinical trial evaluating North Star —an investigational desiccated thyroid extract (DTE) for the treatment of hypothyroidism. The study met its primary endpoint, successfully defining the dose conversion ratio between levothyroxine (LT4) to North Star. The Phase II Trial also demonstrated a favorable safety profile.
Acella Pharmaceuticals is the maker of NP Thyroid®, the #1 prescribed DTE^ in the United States to treat adults with primary hypothyroidism. There are approximately 1.5 million American hypothyroidism patients who rely on DTEs like NP Thyroid®.
“These successful results highlight a critical step forward in the FDA approval process of desiccated thyroid extract. We look forward to continuing to work with the FDA to gain Biologics License Application (BLA) approval of North Star,” said Art Deas, Chief Executive Officer of Acella Pharmaceuticals.
Hypothyroidism is a chronic condition in which the thyroid gland does not produce enough thyroid hormones to meet the body’s needs. Thyroid hormones play a critical role in regulating metabolism, energy production, heart function, and brain health. When these hormones are deficient, patients often experience fatigue, weight gain, depression, sensitivity to cold, and cognitive difficulties.
“These positive results add to the significant body of evidence highlighting why DTE^ products have been utilized for over a century to reliably treat hypothyroidism,” said Francesco S. Celi, MD, MHSc, chair of the Department of Medicine at UConn School of Medicine and UConn Health. “DTEs provide both T4 (thyroxine) and T3 (triiodothyronine), a combination that has been shown in some studies to provide symptom relief to patients who do not feel fully restored on other treatments.”
For this trial, Acella Pharmaceuticals conducted the study under the investigational name North Star through its sister company Neuvosyn Laboratories. Neuvosyn Laboratories develops New Drug Applications and Biologics License Applications for the company.
“Acella is dedicated to working collaboratively with the broader endocrinology and patient community to advance treatment options and ensure that patients have access to dependable, effective therapies,” said Deas. “We are proud to be a U.S.-based pharmaceutical company providing good-paying jobs to hard-working Americans through our domestic manufacturing program. Our goal is to continue to lead the way in advocating for patient choice and scientific innovation in hypothyroidism care.”
About NP Thyroid®
For more information on NP Thyroid®, please visit npthyroid.com. For Important Risk
Information, visit npthyroid.com/iri. For full Prescribing Information, including BOXED
WARNING, visit npthyroid.com/pi. Note that DTE^ products, including NP Thyroid®, have not
been reviewed by the FDA for safety or efficacy. For U.S. residents only.
About Alora Pharmaceuticals, LLC
Alora Pharmaceuticals, LLC is the parent company of six specialty pharmaceutical and
pharmaceutical manufacturing companies with manufacturing facilities in Texas and Georgia.
Headquartered in Alpharetta, GA, Alora is the parent company of the following organizations
that comprise the Alora Family of Companies: Avion Pharmaceuticals, Acella Pharmaceuticals,
Osmotica Pharmaceuticals, Sovereign Pharmaceuticals, Trigen Laboratories, Neuvosyn
Laboratories, and Vertical Pharmaceuticals.
Media Contact
Scott Lusk, [email protected]
For additional information please contact Acella at 678-325-5189 or visit acellapharma.com.
^Based on prescriptions filled, NP Thyroid® is the #1 Prescribed DTE^ in the United States. Source: IQVIA National Prescription Audit (NPA) data on file. Acella Pharmaceuticals, LLC.