Introduction
Trulance, developed by Synergy Pharmaceuticals, is a medication approved for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). This article delves into the clinical trials, market performance, and future projections of Trulance.
Clinical Trials Overview
Study Design and Patient Population
The efficacy and safety of Trulance were established through several clinical trials. For IBS-C, two 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies involved 1453 adult patients who met the Rome III criteria[3][5].
For CIC, two similar studies included 1775 adult patients. These trials assessed patient symptoms daily using electronic diaries[3][5].
Efficacy in IBS-C
In Study 3 of IBS-C patients, Trulance demonstrated a significant improvement over placebo. The percentage of overall efficacy responders, defined as patients who met both abdominal pain intensity and stool frequency criteria for at least 6 of the 12 treatment weeks, was 30% for Trulance versus 18% for placebo (P < 0.001)[1][3].
Efficacy in CIC
In CIC patients, Trulance also showed superior efficacy. The percentage of durable complete spontaneous bowel movement (CSBM) responders was 21% for Trulance versus 10% for placebo (P < 0.005)[1][3].
Secondary Endpoints
Trulance improved various secondary endpoints, including abdominal bloating and cramping. In integrated analyses of IBS-C Studies 3 and 4, Trulance significantly reduced the severity of abdominal bloating and cramping compared to placebo[3].
Straining Scores
For CIC patients, Trulance significantly reduced straining scores by 39% compared to 26% with placebo (P < 0.001), with improvements observed as early as week 1 and maintained throughout the study[3].
Market Analysis
Launch and Sales Performance
Trulance received FDA approval for CIC in January 2017 and for IBS-C in January 2018. Despite initial optimism, including a projected 2018 sales estimate of $100 million, the drug underperformed, with actual sales of $20.8 million for the first half of 2018 and a projected full-year sales of $47 million, far below the minimum revenue requirement of $61 million set by its loan agreement with CRG Servicing[2].
Competitive Landscape
Trulance competes in a crowded market against established drugs like Allergan's Linzess and Takeda’s Amitiza. Despite Synergy's efforts to boost sales, including hiring an experienced sales force from GI competitors, Trulance has struggled to gain significant market share. Barclays analysts have noted that Linzess remains the dominant player due to its wide adoption, overall safety, and first-mover advantage[4].
Financial Challenges
Synergy Pharmaceuticals faced significant financial challenges due to the underperformance of Trulance. The company attempted to sell itself but received offers below its market value. This led to a drastic decline in stock prices and potential bankruptcy if the company could not renegotiate its loan terms with CRG Servicing[2].
Market Projections
Current Market Position
As of the latest data, Trulance continues to face challenges in gaining substantial market traction. The drug's sales have not met initial projections, and the company's financial struggles have impacted its ability to invest in further marketing and sales efforts.
Future Outlook
Despite the current challenges, Trulance has strong clinical evidence supporting its efficacy. The 2020 American College of Gastroenterology (ACG) Clinical Guidelines gave Trulance a strong recommendation with high-quality evidence for treating global IBS-C symptoms, indicating potential for future growth if marketing strategies and financial support improve[1].
International Expansion
Synergy has licensed Trulance’s rights in certain regions, such as China to Luoxin Pharma and Canada to Cipher Pharmaceuticals. These partnerships could provide additional revenue streams, although the timing of milestone payments may not be immediate enough to rescue Synergy from its current financial predicament[2].
Key Takeaways
- Clinical Efficacy: Trulance has demonstrated significant efficacy in clinical trials for both IBS-C and CIC, improving symptoms such as abdominal pain, stool frequency, bloating, and straining.
- Market Challenges: Despite strong clinical data, Trulance has underperformed in the market, failing to meet sales projections and facing stiff competition from established drugs.
- Financial Struggles: Synergy Pharmaceuticals has faced financial difficulties due to the poor sales performance of Trulance, leading to attempts to sell the company and potential bankruptcy.
- Future Potential: With a strong recommendation from the ACG and potential international revenue streams, Trulance could see improved market performance if supported by better marketing and financial strategies.
FAQs
What are the primary indications for Trulance?
Trulance is approved for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC)[1][3].
How does Trulance compare to other treatments in its class?
Trulance competes with drugs like Allergan's Linzess and Takeda’s Amitiza. While it has strong clinical evidence, it has struggled to gain significant market share against these established competitors[4].
What were the key findings from the clinical trials of Trulance?
Clinical trials showed that Trulance significantly improved symptoms such as abdominal pain, stool frequency, bloating, and straining in both IBS-C and CIC patients compared to placebo[1][3].
Why has Trulance underperformed in the market?
Trulance has faced challenges due to stiff competition, inadequate sales performance, and financial struggles of its parent company, Synergy Pharmaceuticals[2].
What are the potential future prospects for Trulance?
Despite current challenges, Trulance has a strong clinical profile and potential international revenue streams. Improved marketing and financial strategies could enhance its market position[1][2].
How has Synergy Pharmaceuticals been affected by the performance of Trulance?
Synergy Pharmaceuticals has faced significant financial difficulties, including a decline in stock prices and potential bankruptcy, due to the underperformance of Trulance[2].
Sources
- Trulance.com: For the treatment of IBS-C and CIC | Trulance® (plecanatide)
- FiercePharma: No sale: After 3 years of hunting a buyer, bruised Trulance maker Synergy desperate for new funding
- Trulance.com: Efficacy Data | Trulance® (plecanatide)
- FiercePharma: Synergy brings 200 representatives on full time as Trulance lands IBS-C nod
- FDA: Drug Trials Snapshots: TRULANCE
