Erectile dysfunction or disorder (ED) is the inability to develop and maintain an erection for the duration of sexual intercourse or activity. Colloquially known as impotence, its prevalence is difficult to ascertain as there are no uniform criteria defining what constitutes ED. Some studies suggest that over 18 million men are affected in the U.S. alone.
What is clear is that ED is increasingly prevalent with age. Estimates suggest that approximately 40 percent of men are affected by age 40, and approximately 70 percent of men are affected at age 70. Potential contributing factors include cardiovascular deterioration, hormonal imbalance, and psychological and/or relationship health. Fortunately, the condition is treatable.
ED is correlated with cardiovascular conditions, obesity, and general health. Lifestyle improvements can, therefore, mitigate erectile function and lessen the rate of decline of function with age.
For example, a year after smoking cessation, patients were found to have a 25 percent improvement in erectile quality. Randomized control trial data suggests that successful weight loss also assists with the resolution of ED.
Several oral medications are available, such as oral phosphodiesterase-5 (PDE5) inhibitor, which is often offered as first-line treatment to patients with ED (unless contraindicated).
Such oral medications enhance the nitric oxide–cGMP pathways to prevent the breakdown of cGMP by PDE5 (i.e. the drug augments the body’s natural erectile mechanism), which means they are unable to offer therapeutic efficacy if any neural conditions or psycho-emotional causes of ED persist.
Intracavernosal self-administration of Trimix is widely-prescribed to treat ED when conventional therapies, such as PDE5 inhibitors, fail. Trimix is a sterile, injectable, three-drug compound that contains the FDA-approved prostaglandin Alprostadil. Patients are trained to inject into the base of the penis.
Trimix offers certain advantages over oral PDE5, including:
- Faster onset
- Fine-tuned dosing
- Fewer drug-drug interactions
- Fewer contraindications
Clinical trials suggest greater than 80 percent satisfaction rate in patients (and their partners).
As the name suggests, Trimix contains three main components:
- Alprostadil (effective dose range 2.5–60 ug)
- Papaverine HCl
- Phentolamine Mesylate
Alprostadil is a vasodilating prostaglandin (a hormone-like compound) with two targeted actions. The first action induces erection by relaxing the blood vessels in the penis. The second action is a suppressive effect on noradrenaline that results in cavernosal arterial dilation. The outcome of both effects is improved blood flow to the penis, causing engorgement (erection). Alprostadil is an FDA-approved treatment for ED. However, with an efficacy rate of 40 to 70 percent, it is often compounded with papaverine and phentolamine to improve outcomes.
Papaverine also acts as a vasodilator and smooth muscle relaxer. There are multiple, complex mechanisms of action. One of the key mechanisms is the inhibition of PDE enzyme, which results in an increase in cGMP in penile tissue. The outcome is smooth muscle relaxation of the arteriolar and arterial walls, which improves blood flow and results in the corpus cavernosum filling with blood (erection).
Phentolamine is an inhibitor that acts by blocking alpha-adrenergic receptors, which further encourages smooth muscle relaxation. The result, then, is a widening of the blood vessels to improve blood flow.
The concentration of these various treatments is personalized to assist each patient with their unique requirements to ensure that the appropriate, effective dose is administered. Test doses are administered for new patients to establish their appropriate dosages. VLS Pharmacy works with prescribers to customize combination therapies and support your treatment plan.
Until recently, the challenge with prescribing Alpostradil-containing compounds was its poor stability, resulting in a limited shelf-life. New advances, however, have provided a much-improved matrix that increases the longevity of the active ingredients.
VLS Pharmacy: Leaders in New Technologies
While Trimix remains a sterile, injectible prescription drug that must be ordered for a specific patient in advance of the compounding, such preparations are now more chemically stable. This stability extends the shelf life of the product and reduces the cost to patients and the healthcare system – without compromising therapeutic efficacy.
Have you ever wondered who makes these breakthroughs that make meaningful differences to the cost and efficacy of treatment plans? The answer is teams of professional pharmacists such as the one that leads VLS Pharmacy. Our own compounding pharmacist-in-charge Gopesh Patel, R. Ph led a recent study — titled Beyond-use Date of Trimix: A Reproducible Stability Study Using Bracketing Design — to demonstrate the shelf-life stability of Trimix.
Through rigorous testing and verifying the reproducibility of results, Patel’s research group was able to test a range of formulations using a bracketed Trimix preparation. Assessing the effects of compounding, storage, and distribution are essential to ensure that the end result is safe for patient use. Using ultra-high-performance liquid chromatography, the team assayed the resultant strength of various formulations and demonstrated that the stability analysis supports the extension of the previous beyond-use date (BUD) for Trimix, allowing for a far more cost-effective treatment strategy.
When you engage VLS Pharmacy to customize your patient’s formulations, you get access to leaders in the field, ready and able to bring innovative research and best practices to improve your patient’s outcomes.
Covid-19 Vaccine at VLS Pharmacy
VLS Pharmacy is currently administering the Moderna Vaccine by appointment only. Before making your appointment, please visit the New York COVID-19 Vaccine Eligibility page here to determine your eligibility. If appointments are unavailable, please check back frequently as New York State is systematically allocating vaccines. As we receive more vaccines, more spots will open.
Please note: we CANNOT book your appointment over the phone due to the screening requirements.
All medications from VLS Pharmacy are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.
Reach out to our team to learn about best practices and to partner with our experts on custom medications for your patients.