Introduction
Naldemedine tosylate, marketed under the brand name Symproic in the US, is a μ-opioid receptor antagonist specifically designed to treat opioid-induced constipation (OIC) in adult patients. Here, we delve into the market dynamics and financial trajectory of this drug.
Market Need and Drivers
The opioid-induced constipation market is driven by the increasing prevalence of chronic pain conditions and the subsequent use of opioid analgesics. Chronic pain affects a significant portion of the population, with approximately 20.4% of adults in the United States experiencing chronic pain[5].
Increasing Prevalence of Chronic Pain
Chronic pain conditions necessitate the long-term use of opioid analgesics, which often lead to OIC. This growing demand for effective treatments for OIC has created a substantial market opportunity for drugs like naldemedine tosylate[3].
Clinical Efficacy and Approval
Naldemedine tosylate was approved by the FDA on March 23, 2017, based on the results of the COMPOSE program, a series of phase three clinical trials. These trials, including COMPOSE-I and COMPOSE-II, demonstrated the efficacy of naldemedine in increasing spontaneous bowel movements in patients with OIC without causing opioid withdrawal symptoms[2].
Clinical Trials Outcomes
The COMPOSE trials showed that patients treated with naldemedine had significantly higher responder rates for spontaneous bowel movements compared to those receiving a placebo. Additionally, a 52-week trial (COMPOSE-III) confirmed the long-term safety and efficacy of naldemedine[2].
Market Segmentation
The OIC drug market is segmented based on the type of drug and the application or distribution channel.
Drug Types
Naldemedine tosylate competes in a market that includes other drugs such as lubiprostone, methyl naltrexone bromide, and alvimopan. Each of these drugs has its own mechanism of action and patient population[3].
Distribution Channels
The market is further segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Naldemedine tosylate is available through these channels, catering to different patient needs and preferences[3].
Commercialization and Partnerships
Naldemedine tosylate is manufactured by Shionogi Inc., a subsidiary of the Japanese pharmaceutical company Shionogi & Co., Ltd. In the US, Shionogi Inc. has partnered with Purdue Pharma for the commercialization of Symproic[2].
Partnership with Purdue Pharma
This partnership has been crucial in promoting and distributing the drug, leveraging Purdue Pharma's expertise in chronic pain management. The collaboration began with the drug's launch in October 2017[2].
Financial Performance
The financial trajectory of naldemedine tosylate is closely tied to the overall performance of its parent company, Shionogi & Co., Ltd., and its partner, Purdue Pharma.
Revenue Growth
Since its FDA approval in 2017, naldemedine tosylate has contributed to the increasing net income of Shionogi & Co., Ltd. The company's net income rose from $66,687,000 in fiscal year 2016 to $83,879,000 in fiscal year 2017, although the exact contribution of Symproic to this growth is not specified[2].
Market Size and Projections
The global OIC drug market, which includes naldemedine tosylate, was valued at USD 2.65 billion in 2023 and is projected to reach USD 3.99 billion by 2032, growing at a CAGR of 4.6%[3].
Pricing and Cost
Naldemedine tosylate is priced at £41.72 for a 28-tablet pack in some markets, reflecting its position as a prescription-only medicine subject to additional monitoring[1].
Safety and Adverse Events
Clinical trials have shown that naldemedine tosylate has a favorable safety profile, with adverse events similar to those in the placebo group. However, patients in the naldemedine group experienced slightly higher rates of adverse events in some studies[2].
Long-Term Safety
The COMPOSE-III trial, which examined the long-term safety of naldemedine, found no significant increase in adverse events or opioid withdrawal symptoms over a 52-week period[2].
Additional Applications
Research has also explored the use of naldemedine in cancer patients with OIC who are insufficiently responding to other treatments. A post hoc analysis of phase IIb and III trials showed that adding naldemedine to magnesium oxide significantly improved bowel movement responder rates in these patients[4].
"In the naldemedine group, the responder rates for spontaneous bowel movement and complete spontaneous bowel movement were 73.3 and 43.1%, respectively, which were significantly higher than in the placebo group"[4].
Conclusion
Naldemedine tosylate has established itself as a significant player in the opioid-induced constipation market, driven by its clinical efficacy and the growing need for effective OIC treatments. The drug's commercial success is supported by its partnership with Purdue Pharma and its inclusion in various distribution channels.
Key Takeaways
- Clinical Efficacy: Naldemedine tosylate has demonstrated significant efficacy in increasing spontaneous bowel movements in patients with OIC.
- Market Growth: The OIC drug market is projected to grow at a CAGR of 4.6% to reach USD 3.99 billion by 2032.
- Partnerships: The partnership with Purdue Pharma has been crucial for the drug's commercialization.
- Safety Profile: Naldemedine tosylate has a favorable safety profile with minimal adverse events.
- Additional Applications: The drug shows promise in treating OIC in cancer patients.
FAQs
What is the primary indication for naldemedine tosylate?
Naldemedine tosylate is primarily indicated for the treatment of opioid-induced constipation in adult patients who have previously been treated with a laxative[1].
Who manufactures naldemedine tosylate?
Naldemedine tosylate is manufactured by Shionogi Inc., a subsidiary of Shionogi & Co., Ltd.[2].
What is the dosage of naldemedine tosylate?
The recommended dosage of naldemedine tosylate is 200 mcg once daily, taken at the same time every day[1].
What are the key clinical trials that supported the approval of naldemedine tosylate?
The COMPOSE program, including COMPOSE-I, COMPOSE-II, and COMPOSE-III trials, supported the FDA approval of naldemedine tosylate[2].
How is naldemedine tosylate distributed in the market?
Naldemedine tosylate is distributed through hospital pharmacies, retail pharmacies, and online pharmacies[3].
Sources
- BMJ - Naldemedine for opioid-induced constipation
- Wikipedia - Naldemedine
- Business Research Insights - Opioid Induced Constipation (OIC) Drug Market
- Oxford Academic - Effect of add-on naldemedine treatment in patients with cancer and ...
- Annual Reports - Form 10-K for Collegium Pharmaceutical INC
