Daiichi Sanyko’s mirogabalin has suicidal ideation, liver function reports in Phase III fibromyalgia program, mirrors Lyrica’s profile – source | BioPharm Insight – 09 Nov 2016 – by Hamish McDougall in London
Daiichi Sanyko’s (TYO:4568) mirogabalin is reporting high adverse rates (AEs), including suicidal ideation and liver function, in an open-label portion of its Phase III fibromyalgia program, said a source familiar with the situation.
Whilst the AEs will not halt the drug’s development, they could damage the company’s intended potential to market mirogabalin as an improved version of Pfizer’s (NYSE: PFE) Lyrica (pregabalin), explained the source.
The side effects are also associated with Lyrica, the source explained.
Daiichi has not publically announced any safety or efficacy concerns and did not respond to a request for comment. One analyst report predicts peak mirogabalin sales of USD 1.5bn.
The AEs themselves are not entirely unexpected based on information provided to investigators and trial sites prior to the program’s launch, however, the frequency of side effects is a little concerning, said the source. The source noted event reports are “piling up.”
Efficacy of Mirogabalin (DS-5565) on Patient-Reported Pain and Sleep Interference in Patients with Diabetic Neuropathic Pain: Secondary Outcomes of a Phase II Proof-of-Concept Study. – PubMed – NCBI . 2017 Mar
To evaluate the effects of mirogabalin on patient-reported pain and sleep interference in diabetic peripheral neuropathic pain (DPNP).
Subjects (N = 452) were randomly assigned (2:1:1:1:1:1:1) to receive
- dose-ranging mirogabalin (5, 10, 15, 20, 30 mg/day), or
- pregabalin (300 mg/day)
for five weeks.
Secondary efficacy end points studied here included
- patient global impression of change (PGIC),
- modified brief pain inventory (BPI), and
- average daily sleep interference score (ADSIS).
Correlation plots were generated to examine the relationship between ADSIS and average daily pain score (ADPS).
At week 5, significant reductions in ADSIS were observed in the mirogabalin 15, 20, and 30 mg/day groups, compared with placebo ( P < 0.05).
Baseline ADSIS and ADPS were strongly correlated ( R 2 = 0.4407), as were mean changes from baseline in ADSIS and ADPS at week 5 ( R 2 = 0.6694).
The mirogabalin 30 mg/day group showed significant improvement compared with placebo in four of six BPI subscales at end point;
the mirogabalin 15 mg/day group showed significant improvement in three of six BPI subscales ( P < 0.05).
At end of treatment, the percentage of subject with PGIC status of “much improved or better” was greater in all mirogabalin dose groups than in the placebo group ( P < 0.05).
I notice that the new drug microgabalin was only compared to placebo, not with the existing drug, pregabalin (Lyrica), even though this was part of the study. This makes me suspect its performance was either equivalent or worse.
This is just another Brand Name drug to take the place of Lyrica which will eventually be available in generic form.
A low incidence of treatment-related adverse events was reported for mirogabalin.
Results support the effectiveness of mirogabalin in improving patient-reported pain and sleep interference in DPNP.