The reclassification of budesonide nasal spray as an over-the-counter (OTC) drug is a major event following the delisting of phenolphthalein tablets.
Budesonide is indicated for the treatment of seasonal and perennial allergic rhinitis, as well as perennial non-allergic rhinitis. According to data from the 2008 Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines, 600 million people worldwide suffer from allergic rhinitis, with a rising prevalence trend.
The switch of budesonide from a prescription drug to an OTC one is set to bring a sharp surge in its sales volume, simply because it will be more accessible to consumers. For any product with inelastic demand, streamlining the purchase process will invariably drive higher consumption.
Epidemiological data on allergic rhinitis in China is incomplete, with the incidence rate varying across different cities. Cities including Chongqing, Chengdu, Urumqi and Nanning see an exceptionally high incidence, ranging from approximately 30% to 37%. Budesonide is a first-line medication and is commonly used for relieving acute inflammatory symptoms of the condition.
Recall the fatal incident some time ago involving a Japanese pharmaceutical company's antifungal medication for tinea pedis, which was contaminated with a hypnotic drug? Falling asleep while driving constitutes a secondary disaster caused by medication, and allergic rhinitis can trigger similar accidents.
Some doctors have simulated the physical state of patients experiencing an allergic reaction while driving: the moments of leaning back, closing the eyes and bowing the head suddenly when sneezing lead to an accident rate comparable to that of drunk driving. Moreover, allergic rhinitis is closely linked to external factors, meaning it lacks the prodromal symptoms seen in other diseases and may flare up immediately upon exposure to allergens. Therefore, avoiding allergen exposure is the utmost priority, yet there is limited official intervention in this regard in China. Due to constraints such as work commitments and financial status, many people are unable to completely avoid contact with allergens.
For those with financial means, they can avoid allergenic factors in a timely manner based on their allergen test results, especially for seasonal pollen allergies. Japan is famous for its cherry blossoms, but a large number of cedar trees are also planted across the country, and cedar is anemophilous. To boost tourism and alleviate the suffering of allergy sufferers, weather forecasts during the flowering period each year specially announce the blooming time of cherry blossoms and cedar trees-the former for the tourism industry, and the latter to remind people to avoid pollen in a timely manner.
In some US states, schools have adopted similar measures; for instance, during the local flowering season, they relocate all students to another state for study tours, which also allows students to experience the customs and cultures of other regions.
Such avoidance methods can indeed reduce the incidence of allergic rhinitis, but they are costly.
In China, the vast majority of people cannot afford such approaches. A student in northern China cannot possibly transfer schools just to avoid the wheat flowering season. This means that most patients have to rely on medication, and budesonide is their first choice. At present, ten relevant budesonide products are traceable in China's market.
Repeat purchases are the core revenue driver for such medications, and given that allergic rhinitis is difficult to cure completely, the reclassification of budesonide as an OTC drug is highly conducive to public medication choices. This also means that there is no such business model as "cutting one's own off" for this drug, and pharmaceutical companies can fully leverage the advantages of their products to cultivate loyal customers. Once such brand preference is formed, the product will gain a stronger competitive edge over others, and this edge is bound to change due to price factors such as volume-based procurement.
However, as a glucocorticoid drug, budesonide carries inherent risks that cannot be overlooked. It may cause systemic glucocorticoid adverse reactions, such as the "cushingoid appearance" (moon face) seen in the infant malformation incident some time ago. Therefore, its use is not recommended for children under six years old, and children aged six to twelve should take it under the guidance of a physician. Immediate drug withdrawal is required if an allergic reaction occurs.
It is crucial to avoid unsupervised medication use to prevent the progression from a single allergic condition to multiple drug-induced complications. Currently, it is a critical time for revising the drug's package insert, and also a moment for pharmaceutical enterprises to make strategic choices-the market for this drug is extremely large in view of the high incidence of allergic rhinitis. It is a regulatory trend for China's drug supervision authorities to gradually relax the access and decision-making power for the use of low-risk established drugs. Of course, the possibility of reclassifying budesonide back to a prescription drug in the future cannot be ruled out, and all of this will depend on the risk-benefit assessment of the product.
With the regulatory restrictions eased, whether the sales volume can be boosted in the future will ultimately hinge on the strategic direction and specific measures of pharmaceutical enterprises.
