Compounding to Ensure Patient Access to Sermorelin

Peptides have received renewed attention recently, especially following the FDA’s most recent advisory committee meeting. The advisory committee evaluated seven peptides for potential inclusion on the Section 503A Bulks List and ultimately decided to recommend six of the seven for inclusion, including BPC-157, KPV, TB-500, MOTS-C, Semax, and Epitalon, but it did not recommend emideltide. The FDA notes that while it generally follows the recommendations of such advisory committees, the recommendations are not legally binding, and the FDA hasn’t issued a final decision yet.

Until then, there are many other peptide-based drugs that have received FDA approval. One of them is sermorelin, which has previously undergone FDA review and received marketing approval for the evaluation and treatment of children with idiopathic or organic growth hormone deficiency and growth failure. 

Since it was discontinued by its manufacturer in 2008, compounding pharmacies remain the only way for patients to access this medication, which is now prescribed off-label in adults for growth hormone deficiency or age-related declines in growth hormones to improve body composition and overall well-being.^1,2

FDA Approval History of Sermorelin

In 1990, the FDA approved Geref Diagnostic (sermorelin acetate) for evaluating the pituitary gland’s capacity to secrete growth hormone. In 1997, Geref was approved for treating idiopathic growth hormone deficiency associated with growth failure in children. In 2008, EMD Serono notified the FDA that it was discontinuing both Geref products and requested withdrawal of their NDAs, so the FDA withdrew approvals in 2009. 

After a review of available evidence, the FDA determined that neither Geref product had been withdrawn for reasons of safety or effectiveness and listed sermorelin acetate in the “Discontinued Drug Product List’’ section of the Orange Book.³ Because of this, sermorelin is not barred from compounding, allowing pharmacies to compound it with a valid patient-specific prescription.

Dosage Forms 

Compounding pharmacies can also provide formulations that were unavailable with the former commercial product when determined necessary by a prescriber. In addition to lyophilized sermorelin acetate for reconstitution and subcutaneous injection, compounding pharmacies can prepare dosage forms like intranasal sprays or buccal/sublingual troches. 

Off-Label Indications

In addition to its historical pediatric indications, sermorelin is now used off-label in adults with growth hormone insufficiency and has been investigated for age-associated declines in growth hormone (GH) secretion. As an analog of growth hormone-releasing hormone (GHRH), sermorelin stimulates the pituitary gland to release endogenous GH. It has been investigated for:

• Adult growth hormone deficiency or growth hormone insufficiency.⁴
• Age-related decline in growth hormone secretion.⁴
• Male hypogonadism as an investigational adjunct intended to stimulate the GH/IGF-1 axis.⁵ 
• Diagnostic evaluation of adult growth hormone deficiency where sermorelin is used as a provocative test of pituitary GH reserve.⁶

Sermorelin is generally well tolerated,⁷ with the most common side effects being redness, pain or swelling at the injection site. Less common side effects include flushing, headaches, sleepiness, or dizziness.

Sourcing Compounded Sermorelin

Compounding is the only way for patients to access sermorelin. Especially for sermorelin injections, prescribers and patients should source compounded sermorelin from a pharmacy equipped with the facilities and expertise that sterile compounding requires. Sterile injectable preparations must be compounded under carefully controlled conditions to minimize the risks of microbial contamination and other quality issues and to help ensure the sterility, potency, and consistency of the finished preparation. 

Please comment below with any thoughts or questions.

Reach out to our team if you have specific questions about our new automated compounding system and compounded medications for your patients. All medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.

References

1. Walker RF. Sermorelin: A better approach to management of adult-onset growth hormone insufficiency? Clin Interv Aging. 2006;1(4):307-308. doi:10.2147/ciia.2006.1.4.307
2. Corpas E, Harman SM, Piñeyro MA, Roberson R, Blackman MR. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men. The Journal of clinical endocrinology and metabolism. 1992;75(2):530-535.
3. Federal Register. U.S. Food and Drug Administration. Determination that GEREF (sermorelin acetate) injection, 0.5 milligrams base/vial and 1.0 milligrams base/vial, and GEREF (sermorelin acetate) injection, 0.05 milligrams base/amp, were not withdrawn from sale for reasons of safety or effectiveness. Published online February 26, 2013. https://www.govinfo.gov/content/pkg/FR-2013-03-04/pdf/2013-04827.pdf
4. Walker RF. Sermorelin: A better approach to management of adult-onset growth hormone insufficiency? Clin Interv Aging. 2006;1(4):307-308. doi:10.2147/ciia.2006.1.4.307
5. Sinha DK, Balasubramanian A, Tatem AJ, et al. Beyond the androgen receptor: the role of growth hormone secretagogues in the modern management of body composition in hypogonadal males. Translational Andrology and Urology. 2020;9(Suppl 2):S149-S14S159. doi:10.21037/tau.2019.11.30
6. Prakash A, Goa KL. Sermorelin. BioDrugs. 1999;12(2):139-157. doi:10.2165/00063030-199912020-00007
7. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-157. doi:10.2165/00063030-199912020-00007

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