Physician Views: Can Flexion's Zilretta carve out a sizeable market?

Late last week, the FDA approved Flexion Therapeutics' Zilretta, the first and only extended-release, intra-articular injection for osteoarthritis (OA) knee pain. Furthermore, Zilretta is a non-opioid medicine that employs Flexion's proprietary microsphere technology to provide demonstrated pain relief over 12 weeks. There is evidence that Zilretta may avoid the disruptive glucose spikes often see with corticosteroids used to treat diabetes patients who have OA knee pain, while the safety profile of Flexion's drug has been compared to placebo.  

These factors support Flexion's argument that Zilretta holds the potential to be a transformative medicine for the more than five million US patients who receive intra-articular injections to relieve OA knee pain each year. That said, while Flexion's pivotal-stage study demonstrated an impressive improvement in pain relief for Zilretta versus placebo, its benefit versus immediate-release triamcinolone was not statistically significant; a potential barrier to adoption for physicians and payers alike.

Therefore, to better understand the commercial outlook for Zilretta, we are snap-polling US rheumatologists with the following questions…

Zilretta – a modified formulation of triamcinolone – has been approved by the FDA as the first and only extended-release, intra-articular injection for osteoarthritis knee pain. Zilretta is a non-opioid medicine that employs proprietary microsphere technology to provide proven pain relief over 12 weeks. The safety profile of Zilretta has been compared to placebo.

In a Phase III trial, Zilretta demonstrated a statistically significant reduction in pain intensity (as measured by weekly mean of Average Daily Pain (ADP) intensity score) versus placebo at week 12. Zilretta also demonstrated a reduction in pain intensity scores each week from Weeks 1 through 12. However, in a secondary exploratory analysis, statistical significance was not demonstrated between Zilretta and immediate-release triamcinolone at Week 12 in weekly mean ADP.

How compelling is Zilretta as a new treatment option?

Very uncompelling

Moderately uncompelling

Slightly uncompelling

Neither compelling or uncompelling

Slightly compelling

Moderately compelling

Very compelling

Will you be discouraged to use Zilretta given that in a secondary exploratory analysis of Phase III data, a statistically significant reduction in pain intensity was not demonstrated between Zilretta and immediate-release triamcinolone?

No – this will not discourage me

Yes – slightly

Yes – moderately

Yes – significantly

Yes – very significantly

Do you anticipate that payers will be discouraged from providing access to Zilretta as a result of this?

No

Yes – slightly

Yes – moderately

Yes – significantly

Yes – very significantly

In a Flexion press release confirming FDA approval of Zilretta, Steven Russell, Assistant Professor of Medicine, Massachusetts General Hospital Diabetes Research Center, noted that "Zilretta may avoid the disruptive blood glucose spikes that can be seen with corticosteroid use in patients coping with both knee OA and type 2 diabetes."

Based on your experience, how would you describe the commercial opportunity for Zilretta in patients with both OA and type 2 diabetes? 

None

Minimal

Moderate

Significant

Very significant

Overall, how quickly would you expect adoption of Zilretta to occur?

None

Slowly

Moderately

Quickly

Very quickly

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions. Note: FirstWord Polls are powered by Medefield MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com.

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