Eptotermin alfa
Also known as: BMP-7, OP-1, OP-1 Implant, OP-1 Putty, Osigraft, rhBMP-7
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Summary
Eptotermin alfa, also known as recombinant human bone morphogenetic protein‑7 (rhBMP‑7) or Osigraft, is a biologic implant used to stimulate bone healing in challenging non‑union fractures and spinal pseudoarthroses. Although once marketed as a prescription product, it has been withdrawn. Clinical reports describe its use as an implantable putty placed during revision surgery to promote fusion where conventional grafting may fail.
Mechanism of Action
BMP‑7 belongs to the transforming growth factor‑β superfamily and binds to type I and II BMP receptors on mesenchymal progenitor cells. Receptor activation triggers SMAD‑1/5/8 phosphorylation, which translocates to the nucleus and up‑regulates osteogenic genes such as RUNX2 and Osterix. This cascade drives differentiation of progenitors into osteoblasts, enhances extracellular matrix production, and promotes new bone formation at the implantation site.
What the Research Shows
Three peer‑reviewed studies provide the current evidence base. A 2016 retrospective follow‑up of 74 lumbar revision surgeries using eptotermin alfa with autologous graft reported an 81 % fusion success rate; ectopic bone formation occurred in one patient. A 2015 observational study of complex long‑bone non‑unions found rhBMP‑7 to be statistically equivalent to autologous bone graft in achieving union, with lower intra‑operative blood loss, shorter operative times, and fewer donor‑site pain events. A 2013 cost‑effectiveness analysis of tibial non‑unions showed higher initial product costs for rhBMP‑7 but reduced follow‑up expenses, yielding a lower average cost per successful outcome and favorable cost‑per‑QALY ratios. All studies are retrospective and lack randomised control groups.
Reported Benefits
Evidence suggests eptotermin alfa can achieve bone union rates comparable to autologous grafts in difficult non‑unions, including lumbar pseudoarthroses and long‑bone fractures. Its use may reduce operative blood loss, shorten surgery duration, and avoid donor‑site morbidity associated with autograft harvest. Some analyses indicate a lower overall cost per successful outcome when follow‑up expenses are considered.
Limitations of the Evidence
The data are limited to retrospective, single‑center series with modest sample sizes; no randomized controlled trials have been published. Long‑term safety beyond the reported follow‑up periods remains uncertain, and rare complications such as ectopic bone formation have been noted. The product’s withdrawn status restricts current clinical availability, and regulatory approval details are not provided in the literature.
Safety Considerations
Adverse events appear uncommon; one study reported a single case of symptomatic ectopic bone formation. Compared with autologous graft, rhBMP‑7 was associated with fewer peri‑operative and late adverse events, largely due to the absence of donor‑site pain. Potential unknown long‑term effects and rare ectopic ossification warrant caution, especially in multi‑level spinal revisions.
How It Is Administered
Eptotermin alfa is supplied as an implantable formulation (e.g., putty or carrier matrix) that is mixed with a carrier and placed directly into the surgical defect during open revision or fracture‑repair procedures. The route of administration is intra‑operative implantation at the target bone site; no systemic dosing is involved.
Routes of Administration
Goals & Uses
- Bone graft substituteOrthopedicModerate
- Long bone nonunion repairOrthopedic / Bone HealingModerate
- Posterolateral lumbar spinal fusionOrthopedic / SpineModerate
Contraindications
- Infection at surgical siteInfectionHigh
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Skeletal immaturityPatient Age/developmentHigh
- Known hypersensitivity to BMP-7 or bovine collagenAllergy/HypersensitivityHigh
- Active malignancy or history of cancer at implant siteOncologyHigh
Adverse Effects
- Retrograde ejaculationReproductiveUncommon
- Implant site pain and swellingLocal ReactionCommon
- Osteolysis / bone resorptionMusculoskeletalUncommon
- Ectopic bone formationMusculoskeletalUncommon
- Antibody formation to BMP-7 or bovine collagenImmunologicUncommon
Drug Interactions
- NSAIDsLowMay increase renal risk in susceptible patients
- CorticosteroidsModerate
Population Constraints
- Pediatric patients (skeletally immature)AgeAbsolute
- Patients with bovine collagen allergyAllergyAbsolute
- Immunocompromised patientsImmunologicRelative
- Pregnant womenReproductiveAbsolute
Regulatory Status
- European UnionWithdrawnApproved: Treatment of tibial nonunions in adults (Osigraft)EMA approved Osigraft (eptotermin alfa) for tibial nonunions; marketing authorization subsequently lapsed/withdrawn.
- United StatesWithdrawnApproved: Recalcitrant long bone nonunions (HDE), Posterolateral lumbar spinal fusion as alternative to autograft in patients with failed previous fusion (HDE)Approved under Humanitarian Device Exemption (HDE). Stryker Biotech withdrew the product voluntarily from the US market circa 2009–2012 amid regulatory and legal issues.
- United KingdomWithdrawnApproved: Tibial nonunionsFollowed EU authorization; no longer marketed.
Received FDA Humanitarian Device Exemption (HDE) approval for recalcitrant long bone nonunions and later for posterolateral lumbar spinal fusion in the US. EMA granted conditional/limited authorization in some EU jurisdictions. Stryker Biotech voluntarily withdrew the product from the US market; criminal charges against Stryker Biotech executives related to off-label promotion contributed to market exit.
Evidence & Sources
- Journal ArticleLowWerle S, AbuNahleh K, Boehm H2016-01-01T00:00:00.000000Z
- Journal ArticleLowCalori GM, et al.2015-01-01T00:00:00.000000Z
- Journal ArticleLowGiorgio Calori M, et al.2013-01-01T00:00:00.000000Z
Frequently Asked Questions
What clinical situations is eptotermin alfa used for?
It has been applied in revision spinal fusion for lumbar pseudoarthrosis and in complex long‑bone non‑unions where standard autograft may be insufficient or undesirable.
How does eptotermin alfa compare to autologous bone graft in terms of effectiveness?
Observational studies report comparable union rates to autograft, with some advantages such as reduced operative blood loss and fewer donor‑site complications, although high‑quality randomized data are lacking.
Are there any serious safety concerns with using eptotermin alfa?
Serious adverse events are rare; the most notable reported issue is a single case of ectopic bone formation. Overall, the safety profile appears favorable compared with autograft, but long‑term data are limited.
Why is the product no longer available on the market?
The structured data indicate the compound has been withdrawn, but the abstracts do not provide a specific reason; withdrawal may relate to commercial, regulatory, or safety considerations not detailed in the literature.
Can eptotermin alfa be administered non‑surgically?
No. The formulation is designed for direct implantation into bone defects during surgery; there is no evidence of systemic or non‑invasive delivery methods.
What is Eptotermin alfa?
Eptotermin alfa, also known as recombinant human bone morphogenetic protein‑7 (rhBMP‑7) or Osigraft, is a biologic implant used to stimulate bone healing in challenging non‑union fractures and spinal pseudoarthroses. Although once marketed as a prescription product, it has been withdrawn. Clinical reports describe its use as an implantable putty placed during revision surgery to promote fusion where conventional grafting may fail.
What is Eptotermin alfa used for?
Eptotermin alfa is educationally associated with: Bone graft substitute, Long bone nonunion repair, Posterolateral lumbar spinal fusion. Educational only — not medical advice.
How is Eptotermin alfa administered?
Recorded routes of administration: Implantation.
What are the potential side effects of Eptotermin alfa?
Reported adverse effects include: Retrograde ejaculation, Implant site pain and swelling, Osteolysis / bone resorption, Ectopic bone formation, Antibody formation to BMP-7 or bovine collagen. This list is not exhaustive — consult a qualified clinician.
Who should avoid Eptotermin alfa?
Recorded contraindications: Infection at surgical site, Pregnancy, Skeletal immaturity, Known hypersensitivity to BMP-7 or bovine collagen, Active malignancy or history of cancer at implant site. Consult a qualified clinician before use.