Pharmaceutical naming is tricky enough. But how about when it comes to naming an asset that is being studied for one than one indication? We’ve got you covered.
Often when a biopharma company has an asset in development that is being studied for more than one indication, we are asked the question, “Should we create a brand name for each indication?” This is known as a dual-name naming strategy. While it seems like a straightforward question that should have a simple answer, the response we give is, “No two cases are alike—it depends.”
As seen in the table below, we can point to several examples of a dual name, where the same medicinal ingredient is marketed for different uses under different names. Each of these examples (both historical and recent) has its own nuances that were likely considerations when the nomenclature strategy was in development.
Name and indication A
Name and indication B
|Sarafem, premenstrual dysphoric disorder
|Proscar, benign prostatic hyperplasia
|Propecia, male pattern hair loss
|Zyban, smoking cessation
|Xgeva, cancer-related bone issues
|Wegovy, obesity management
Considering a Dual-Name
Despite these dual-named drugs, previously approved examples may not be a good prognosticator of what may be appropriate for an upcoming asset. Those answers lie strategically at the intersection of branding and patient safety, with an overlay of commercial goals along with the standards set by regulatory bodies.
Anyone who has been through the process of pharmaceutical naming knows that regulatory bodies can reject a proposed name due to potential confusion resulting in a patient receiving the wrong medication. While this is true in all naming situations, when considering a dual name, another layer of complexity must be considered.
Factors that determine whether the dual-name approach is a reasonable option from a patient safety standpoint may include:
Different prescribers but same patient population
A medication indicated for vastly different uses and made available under two names may be prescribed by different specialists. If the prescriptions are not filled by the same pharmacy (which would detect duplicate therapy), the patient would receive the same medicinal ingredient from two sources. The potential harm from additive or duplicate therapy must be considered in cases where the proposed patient population for product could overlap. This scenario may be less likely when patient populations are not likely to intersect.
Dose and administration schedule
If the dose and administration schedules for the two products are different, it could be possible for the patient to receive “Name A” with the directions for “Name B.” For instance, if “Name A” is administered once daily and “Name B” is administered once weekly and the directions were confused during the prescribing or dispensing process, a patient could receive a product every day when it is intended for weekly use. The patient would receive seven times the intended amount of medication, which, depending on the drug and disease state, could lead to serious harm.
Determining If a Dual-Name Strategy Is Right for You
The above examples are just two scenarios of many that should be examined when considering a dual name for a product with different indications. The assessment of dual naming is rooted in Failure Mode and Effects Analysis (FMEA). Broadly stated, FMEA answers the questions, “What could go wrong (the failure mode) and what would the outcome be (the effects)?” A risk assessment using FMEA should be considered as part of the naming strategy for any asset being developed for more than one indication. The study will examine the indication, disease state, dose and dosing regimen, prescriber type and patient population, as well as any unique aspects of distribution, dispensing and administration. The outcome of the risk assessment will help inform whether a dual name is an appropriate pathway for your asset and help guide custom pharmaceutical naming and branding recommendations that make sense from a commercial and regulatory standpoint.