The Discontinuation of Brand-Name Axiron
Axiron (testosterone) was an androgen topical solution approved by the U.S. Food and Drug Administration (FDA) in 2010 for replacement therapy in males with conditions related to low or absent endogenous testosterone. Unlike other gels applied to the shoulders or abdomen, Axiron was uniquely formulated for application to the armpit with a metered-dose pump. The drug quickly gained popularity, achieving significant market share after its launch in 2011.
However, in September 2017, Eli Lilly and Company, the market holder for Axiron, announced its decision to discontinue the brand-name product. This decision was not triggered by a recall or concerns over the drug's safety or efficacy. Instead, it was a business-driven choice influenced by several market dynamics. One major factor was the increase in generic competition following patent challenges. As other manufacturers introduced generic versions of the testosterone topical solution, the market for the brand-name product became less commercially viable for Eli Lilly.
The FDA's Official Determination
To clarify the reasons for Axiron's withdrawal, the FDA formally determined that the product was not withdrawn from sale for reasons of safety or effectiveness. This meant that generic competitors were allowed to continue marketing their products without facing any regulatory obstacles related to the brand's withdrawal. This regulatory step is crucial for the generic drug industry, as it prevents brand manufacturers from using non-safety-related withdrawals to block competition. The FDA's stance confirms that the discontinuation was a commercial decision, not a safety one.
Testosterone Safety Concerns and Lawsuits
Despite the specific reason for Axiron's withdrawal, it is important to note that the broader class of testosterone replacement therapies has been under scrutiny for potential safety risks. Beginning in 2014, the FDA announced an investigation into the risks of heart attack, stroke, and death in men using FDA-approved testosterone products. Following this, the FDA required updated labeling for all testosterone products to warn of these potential cardiovascular risks. The ongoing need for post-marketing trials to assess cardiovascular safety was another commercial consideration in Eli Lilly's decision to exit the market. In addition, Axiron faced multidistrict litigation concerning potential cardiovascular events, and Eli Lilly settled hundreds of lawsuits in late 2017.
Therapeutically Equivalent Generic Alternatives
For patients who previously used Axiron, or for those seeking a similar treatment, several therapeutically equivalent generic alternatives are available. The FDA has approved several generic versions of testosterone topical solution (30 mg/1.5mL actuation) from manufacturers like Lupin, Cipla, and others. These products contain the same active ingredient and are designed to deliver the same therapeutic effect as the original Axiron. Patients transitioning from the brand-name product can work with their doctor and pharmacist to ensure they receive a suitable and effective generic version.
How to Transition to a Generic or Alternative
Transitioning from a brand-name medication to a generic or another alternative should always be done under the supervision of a healthcare provider. Here are the typical steps:
- Consult Your Doctor: Discuss the switch with your doctor to confirm that a generic testosterone topical solution is appropriate for you. Your doctor will ensure the dosage and administration instructions are correct.
- Speak with Your Pharmacist: Your pharmacist can provide information on the available generic options and help navigate any insurance or cost differences.
- Review Administration Instructions: Even for generic versions, it is important to read the package insert carefully. While the medication is the same, the applicator or specific instructions might differ slightly from what you are used to with the brand-name product.
- Monitor Effects: After starting the new medication, pay attention to how your body responds and communicate any concerns or side effects to your doctor.
Other Testosterone Replacement Therapy (TRT) Options
Beyond the generic versions of Axiron, several other forms of TRT are available for men with diagnosed hypogonadism. A patient's preference, lifestyle, and medical history will influence which option is best. Here is a brief overview:
- Other Topical Gels: Products like Androgel, Testim, and Vogelxo are applied to the shoulders and upper arms or abdomen. They offer a simple, daily application method, but require caution to prevent accidental transfer to others.
- Injections: Testosterone injections (e.g., testosterone cypionate or enanthate) are administered intramuscularly, typically every one to two weeks, and are often a cost-effective option.
- Patches: Transdermal patches (e.g., Androderm) are applied daily to the skin, providing a steady release of testosterone.
- Pellets: Implantable pellets (e.g., Testopel) are surgically inserted under the skin and provide a continuous release of testosterone for three to six months.
- Nasal Gels: Natesto is a gel applied inside the nostrils multiple times a day.
Comparison of TRT Options
| Feature | Generic Testosterone Topical Solution | Androgel / Other Gels | Testosterone Injections | Testosterone Pellets (Testopel) |
|---|---|---|---|---|
| Application Site | Underarm (axilla) | Shoulders, upper arms, abdomen, or thighs | Intramuscular (e.g., gluteal muscle) | Subcutaneously (e.g., buttock, flank) |
| Frequency | Once daily | Once daily | Typically every 1-2 weeks | Every 3-6 months |
| Risk of Transfer | Minimized due to concealed application site | Higher risk of accidental transfer | Negligible | Negligible |
| Cost | Often a lower-cost generic option | Varies; brand names can be expensive | Cost-effective | Can be more expensive up front |
| Side Effects | Skin irritation, other testosterone-related effects | Skin irritation, other testosterone-related effects | Pain at injection site, hormonal fluctuations | Potential for bleeding, infection, or extrusion at implant site |
Conclusion
While the brand-name product Axiron is no longer available in the U.S. market, its discontinuation in 2017 was due to market competition rather than safety or effectiveness concerns. Fortunately, patients who relied on this medication can access therapeutically equivalent generic versions, which have been approved by the FDA. Numerous other forms of testosterone replacement therapy also offer viable alternatives depending on a patient's specific needs and lifestyle. Anyone considering a transition from Axiron or exploring new TRT options should consult with a healthcare provider to determine the best course of action.
For more detailed information on discontinued drugs and FDA determinations, visit the official Federal Register website.
